BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2230013 · Received August 31, 2011

    Report

    Report Number
    3006630150-2011-01337
    Event Type
    Injury
    Date Received
    August 31, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 4, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS DID NOT CONFIRM THE COMPLAINT. THE IPG PASSED ALL ELECTRICAL, PERFORMANCE, VISUAL INSPECTION AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE AMPLITUDE AND PULSE WIDTH OF THE SETTING WERE VERIFIED TO BE CORRECT ON ALL ELECTRODES AS IT WAS PROGRAMMED. AFTER TURNING OFF THE STIMULATION, ALL 16 ELECTRODES WERE RECHECKED FOR ANY OUTPUT AND FOUND NO STIMULATION OUTPUT. VISUAL INSPECTION OF THE LEAD REVEALED THAT IT WAS PULLED AND CUT. THE DAMAGE TO THE DEVICE IS A RESULT OF A TYPICAL EXPLANT PROCEDURE AND IS NOT CONSIDERED A FAILURE. THE DEVICE EXHIBITED NORMAL DEVICE CHARACTERISTICS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL # SC-8216-70 SERIAL # (B)(4) DESCRIPTION: ARTISAN 2X8 PADDLE LEAD (LIM), 70 CM. THE EXPLANTED LEAD WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT WAS RECEIVING STIMULATION FROM HEAD TO TOE WHETHER THE DEVICE WAS ON OR OFF. THE PHYSICIAN BELIEVED THAT NOTHING WAS WRONG WITH THE DEVICE. THE PATIENT WAS PRESCRIBED NEURONTIN FOR THE UNCOMFORTABLE STIMULATION, HOWEVER, THE ISSUE WAS NOT RESOLVED. THE PATIENT'S SYSTEM WAS EXPLANTED AND THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT WAS RECEIVING STIMULATION FROM HEAD TO TOE WHETHER THE DEVICE WAS ON OR OFF. THE PHYSICIAN BELIEVED THAT NOTHING WAS WRONG WITH THE DEVICE. THE PATIENT WAS PRESCRIBED NEURONTIN FOR THE UNCOMFORTABLE STIMULATION, HOWEVER, THE ISSUE WAS NOT RESOLVED. THE PATIENT'S SYSTEM WAS EXPLANTED AND THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention