BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 2870370 · Received December 12, 2012

    Report

    Report Number
    3006630150-2012-02326
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    October 19, 2012
    Report Date
    October 22, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. IT IS INDICATED THAT THE DEVICES WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MED WATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    SC-8216-70 (SN (B)(4)). THE COMPLAINT OF HIGH IMPEDANCE COULD NOT BE CONFIRMED. THE PADDLE LEAD HAD BEEN SEVERELY DAMAGED UPON RECEIVING. THE LEAD BODIES HAVE SEVERAL FRACTURED CABLES AT THE BURNED/MELTED PORTIONS OF THE LEAD. THE BURN MARKS ARE TYPICALLY CAUSED BY THE USE OF ELECTROCAUTERY. IT WAS REPORTED THAT ELECTROCAUTERY WAS USED DURING THE EXPLANT PROCEDURE. IT COULD NOT BE DETERMINED IF THE LEAD WAS DAMAGED PRIOR TO THE EXPLANT PROCEDURE DUE TO THE BURNED CABLES AND INSULATION ALONG THE LEAD BODIES. ADDITIONALLY, THE LEAD BODIES WERE ALSO CLEANLY CUT. THE CUT DAMAGE IS A RESULT OF A TYPICAL EXPLANT PROCEDURE AND IT IS NOT CONSIDERED A FAILURE. ELECTRICAL TESTING COULDN'T BE PERFORMED DUE TO THE SEVERE DAMAGE TO THE LEAD BODIES. SC-1110 (SN (B)(4)) DEVICE EVALUATION INDICATED THAT THE IPG PASSED PHOTOGRAPHIC TESTS PERFORMED. THE COMPLAINT OF HIGH IMPEDANCE WAS NOT VERIFIED. HOWEVER, THE DEVICE'S ANALOG INTEGRATED CIRCUIT (AIC) WAS DAMAGED. THE AIC DAMAGE RESULTED IN THE RAPID BATTERY DEPLETION RATE OF THE IPG WITHOUT STIMULATION TURNING ON. IT COULD NOT BE DETERMINED WHEN THE DAMAGE OCCURRED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING HIGH IMPEDANCES. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG AND THE LEADS WERE REPLACED. THE IPG WAS REPLACED PER PHYSICIAN'S PREFERENCE. THE PATIENT WAS REPORTEDLY DOING WELL AFTER THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING HIGH IMPEDANCES. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG AND THE LEADS WERE REPLACED. THE IPG WAS REPLACED PER PHYSICIAN'S PREFERENCE. THE PATIENT WAS REPORTEDLY DOING WELL AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR