Precision™ Plus Spinal Cord Stimulator System

Prescriptive Information

Not intended as a substitute for the provided Patient System Handbook or the Patient Trial Handbook. The contents of the handbooks must be fully understood before using your Precision Plus System.

Indications for Use

The Precision™ Spinal Cord Stimulator System (Precision System) is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain, and leg pain.

Contraindications

Patients contraindicated for permanent SCS therapy are those who:

  • are unable to operate the SCS system
  • have failed trial stimulation by failing to receive effective pain relief
  • are poor surgical risks
  • are pregnant

Warnings

Heat Due to Charging.

Do not charge while sleeping. This may result in a burn. While charging, the Charger may become warm. It should be handled with care. Failure to use the Charger with either the Charging Belt or an adhesive patch, as shown, may result in a burn. If you experience pain or discomfort, cease charging and contact Boston Scientific.

Magnetic Resonance Imaging (MRI).

Patients implanted with the Precision System should not be subjected to MRI. MRI exposure may result in dislodgement of implanted components, heating of the neurostimulator, damage to the device electronics and/or voltage induction through the leads and Stimulator causing an uncomfortable or "jolting" sensation.

Pediatric Use.

The safety and effectiveness of spinal cord stimulation has not been established for pediatric use.

Diathermy.

Shortwave, microwave and/or therapeutic ultrasound diathermy should not be used on SCS patients. The energy generated by diathermy can be transferred through the Stimulator system, causing tissue damage at the lead site which may result in severe injury or death. The IPG, whether it is turned on or off, may be damaged.

Implanted Stimulation Devices.

Spinal cord stimulators may interfere with the operation of implanted sensing stimulators such as pacemakers or cardioverter defibrillators. The effects of implanted stimulation devices on neurostimulators is unknown.

Stimulator Damage.

Burns may result if the pulse generator case is ruptured or pierced and patient tissue is exposed to battery chemicals. Do not implant the device if the case is damaged.

Postural Changes.

Patients should be advised that changes in posture or abrupt movements may cause decreases, or uncomfortable or painful increases in the perceived stimulation level. Patients should be advised to turn down the amplitude or turn off the IPG before making posture changes. If unpleasant sensations occur, the IPG should be turned off immediately.

Electromagnetic Interference.

Strong electromagnetic fields can potentially turn the Stimulator off, or cause uncomfortable or jolting stimulation. Patients should be counseled to avoid or exercise care around:

  • Theft detectors or security screeners such as those used at entrances/exits of department stores, libraries, and other public establishments, and/or airport security screening devices. It is recommended that patients request assistance to bypass the device. If they must proceed through the device, the patient should turn off the Stimulator and proceed with caution, ensuring to move through the center of the screener as quickly as possible.
  • Power lines or power generators
  • Electric steel furnaces and arc welders
  • Large, magnetized stereo speakers

Precautions

Physician training is required.

Medical Devices/Therapies.

The following medical therapies or procedures may turn stimulation off or may cause permanent damage to the Stimulator, particularly if used in close proximity to the device:

  • lithotripsy
  • electrocautery: Do not use monopolar cautery.
  • external defibrillation
  • radiation therapy
  • ultrasonic scanning
  • high-output ultrasound

If any of the above is required by medical necessity, refer to "Instructions for the Physician" page 15. Ultimately, however, the device may need to be explanted as a result of associated failure.

Automobiles and Other Equipment.

Patients should not operate automobiles, other motorized vehicles, or potentially dangerous machinery/equipment with therapeutic stimulation switched on. Stimulation must be turned off first. Sudden stimulation changes, if they occur, may distract patients from attentive operation of the vehicle or equipment.

Post Operative.

During the two weeks following surgery, it is important to use extreme care so that appropriate healing will secure the implanted components and close the surgical incisions:

  • Do not lift objects of more than five pounds.
  • Do not engage in rigorous physical activity such as twisting, bending, or climbing.
  • If new leads were implanted, do not raise your arms above your head.

Temporarily, there may be some pain in the area of the implant as the incisions heal. If discomfort continues beyond two weeks, contact your physician.

If you notice excessive redness around the wound areas during this time, contact your physician to check for infection and administer proper treatment. In rare cases, adverse tissue reaction to implanted materials can occur during this period.

Be sure to consult your physician before making lifestyle changes due to decreases in pain.

Stimulator Location.

Never attempt to change the orientation or "flip" the Stimulator. Do not "finger" or play with the Stimulator. If the Stimulator flips over in your body, it cannot be charged. If you know that the device has turned, or if stimulation cannot be turned on after charging, contact your physician to arrange an evaluation of the system. In some cases, the skin over your Stimulator may become very thin over time. If this occurs, contact your physician.

Lead Location.

In some instances a lead can move from its original location, and stimulation at the intended pain site can be lost. If this occurs, consult your physician who may able to restore stimulation by reprogramming the Stimulator in the clinic or repositioning the lead during another operation.

Device Failure.

Stimulators can fail at any time due to random component failure, loss of battery functionality, or lead breakage. If the device stops working even after complete charging (up to four hours), turn off the Stimulator and contact your physician so that the system can be evaluated.

Storage, Handling and Transport.

Do not expose the Remote Control or Charging System components to excessively hot or cold conditions. Do not leave the devices in your car or outdoors for extended periods of time. The sensitive electronics can be damaged by temperature extremes, particularly high heat. For proper operation, do not use the Charger if the ambient temperature is above 95 °F (35 °C).

If the Remote Control or the Charging System is to be stored for a period of time without batteries, the storage temperature should not exceed -4 to 140 °F (-20 to 60 °C).

Handle the system components and accessories with care. Do not drop them or submerge them in water. Although reliability testing has been performed to ensure quality manufacturing and performance, dropping the devices on hard surfaces or in water, or other rough handling, can permanently damage the components. (See "Limited Warranty" page 63.)

Component Disposal.

Do not dispose of the Remote Control or Charger in fire. The battery in these devices can explode in fire. Dispose of used batteries in accordance with local regulations. The IPG should be explanted in the case of cremation, and returned to Boston Scientific. External devices to be disposed of per local regulatory requirements. Please contact your healthcare professional.

Remote Control, Charging System Cleaning.

The components can be cleaned using alcohol or a mild detergent applied with a cloth or tissue. Residue from soapy detergents should be removed with a damp cloth. Do not use abrasive cleansers for cleaning.

Cell Phones.

While we do not anticipate any interference with cell phones, the full effects of interaction with cell phones are unknown at this time. If there is a concern or a problem is encountered, the physician should be contacted.

Adverse Effects

Potential risks are involved with any surgery. In addition to those typically associated with surgery, the possible risks of stimulation system implantation include:

  • Lead migration, resulting in undesirable changes in stimulation and subsequent reduction in pain relief.
  • System failure, which can occur at any time due to random failure(s) of the components or the battery. These events, which may include device failure, lead breakage, hardware malfunctions, loose connections, electrical shorts or open circuits and lead insulation breaches, can result in ineffective pain control.
  • Tissue reaction to implanted materials can occur.  In some cases, the formation of reactive tissue around the lead in the epidural space can result in delayed onset of spinal cord compression and neurological/sensory deficit, including paralysis.  Time to onset is variable, possibly ranging from weeks to years after implant.
  • Skin erosion at the IPG site can occur over time.
  • Possible surgical procedural risks are: temporary pain at the implant site, infection, cerebrospinal fluid (CSF) leakage and, although rare, epidural hemorrhage, seroma, hematoma and paralysis.
  • External sources of electromagnetic interference may cause the device to malfunction and affect stimulation.
  • Exposure to MRI can result in heating of tissue, image artifacts, induced voltages in the neurostimulator and/or leads, lead dislodgement.
  • Undesirable stimulation may occur over time due to cellular changes in tissue around the electrodes, changes in electrode position, loose electrical connections and/or lead failure.
  • The patient may experience painful electrical stimulation of the chest wall as a result of stimulation of certain nerve roots several weeks after surgery.
  • Over time, the Stimulator may move from its original position.
  • Weakness, clumsiness, numbness or pain below the level of implantation.
  • Persistent pain at the IPG or lead site.

In any event, instruct the patient to contact their physician to inform him/her.

CAUTION: Federal law restricts this device to the sale, distribution and use by or on the order of a physician.