BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION SPECTRA®

    MDR report key: 3924427 · Received July 9, 2014

    Report

    Report Number
    3006630150-2014-01370
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2316-50, SERIAL/LOT #: (B)(4), DESCRIPTION: INFINION 1X16 PERC LEAD KIT-50 CM; MODEL #: SC-3400-30, SERIAL/LOT #: (B)(4), DESCRIPTION: INFINION SPLITTER 2X8 KIT (30 CM).

    Additional Manufacturer Narrative · 1

    SC-2316-50 (SN-(B)(4)): DEVICE EVALUATION INDICATED THAT THE LEAD PASSED THE MECHANICAL TESTS PERFORMED. THE COMPLAINT WAS CONFIRMED. VISUAL INSPECTION REVEALED THE LEAD BODY HAD A PRONOUNCED KINK APPROXIMATELY 18 CM FROM THE DISTAL END, WHERE THE LEAD APPEARED TO HAVE BEEN SUTURED. ALL CABLES WERE BROKEN/SEVERED AT THIS SPOT. THE FRACTURE SITES WERE WITHIN A 1 CM AREA SURROUNDING THE CLIK ANCHOR SETSCREW MARK. THIS APPEARED TO HAVE BEEN CAUSED BY FATIGUE POSSIBLY COUPLED WITH POSTURAL CHANGES/MOVEMENTS. THE SEVERED CABLES WERE THE REASONS FOR THE HIGH IMPEDANCES OBSERVED. SC-2316-50 (SN-(B)(4)): DEVICE EVALUATION INDICATED THAT THE LEAD PASSED THE MECHANICAL TESTS PERFORMED. THE COMPLAINT WAS CONFIRMED. VISUAL INSPECTION REVEALED THE LEAD BODY HAD A PRONOUNCED KINK APPROXIMATELY 18 CM FROM THE DISTAL END, WHERE THE LEAD APPEARED TO HAVE BEEN SUTURED. THIRTEEN CABLES WERE BROKEN/SEVERED AT THIS SPOT. THE FRACTURE SITES WERE WITHIN A 1 CM AREA SURROUNDING THE CLIK ANCHOR SETSCREW MARK. THIS APPEARED TO HAVE BEEN CAUSED BY FATIGUE POSSIBLY COUPLED WITH POSTURAL CHANGES/MOVEMENTS. THE SEVERED CABLES WERE THE REASONS FOR THE HIGH IMPEDANCES OBSERVED. SC-3400-30 (SN-(B)(4)): DEVICE EVALUATION INDICATED THAT THE SPLITTERS PASSED THE VISUAL, ELECTRICAL, MECHANICAL AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE COMPLAINT OF HIGH IMPEDANCE WAS NOT CONFIRMED. THE SPLITTERS PASSED IMPEDANCE TEST. THE SPLITTERS WERE ALSO ROTATED IN SEVERAL DIRECTIONS TO DUPLICATE THE REPORTED COMPLAINT WITH NO ANOMALIES DETECTED. THEREFORE, THE REPORTED COMPLAINT OF HIGH IMPEDANCE COULD NOT BE DUPLICATED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT¿S LEADS WERE PRODUCING HIGH IMPEDANCES. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS AND LEAD SPLITTERS WERE REPLACED. MALFUNCTION WAS SUSPECTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT¿S LEADS WERE PRODUCING HIGH IMPEDANCES. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS AND LEAD SPLITTERS WERE REPLACED. MALFUNCTION WAS SUSPECTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401598 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR