BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 2898199 · Received January 7, 2013

    Report

    Report Number
    3006630150-2012-02460
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Date of Event
    July 11, 2011
    Report Date
    August 22, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL, ELECTRICAL, PERFORMANCE AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE IPG WAS VERIFIED TO BE WORKING AS EXPECTED. (B)(4) THE COMPLAINT WAS CONFIRMED. ALTHOUGH THE PADDLE LEAD WAS PULLED AND CUT DURING THE EXPLANT PROCEDURE, ALL THE WIRES OF THE RIGHT SIDE OF THE LEAD WERE ALL FRAGMENTED AT THE SUTURE SITE. THIS EVENT WOULD CAUSE STIMULATION INTERMITTENT, LOSS AND HIGH IMPEDANCE READINGS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-8120-70, SERIAL #: (B)(4), DESCRIPTION: ARTISAN SURGICAL LEAD, 70CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT RE-IMPLANT PROCEDURE DUE TO HIGH IMPEDANCES. IT WAS THE PHYSICIAN'S PREFERENCE THAT THE OLD SYSTEM WAS REPLACED WITH A NEW ONE. DEVICE MALFUNCTION WAS SUSPECTED. THE PATIENT WAS REPORTEDLY DOING WELL AFTER THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT RE-IMPLANT PROCEDURE DUE TO HIGH IMPEDANCES. IT WAS THE PHYSICIAN'S PREFERENCE THAT THE OLD SYSTEM WAS REPLACED WITH A NEW ONE. DEVICE MALFUNCTION WAS SUSPECTED. THE PATIENT WAS REPORTEDLY DOING WELL AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7778 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR