BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 2944779 · Received February 5, 2013

    Report

    Report Number
    3006630150-2013-00213
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 6, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WILL NOT UNDERGO A POCKET REVISION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS NOTED TO HAVE HAD A BACK SURGERY IN THE PAST ON WHICH ELECTROCAUTERY WAS USED. FURTHERMORE, THE PATIENT UNDERWENT A REVISION WHEREIN THE IPG WAS REPLACED WITH A NEW ONE. THE PATIENT WAS DOING WELL POSTOPERATIVELY. MONOPOLAR ELECTROCAUTERY IS A KNOWN SOURCE OF HIGH VOLTAGE TRANSIENT SIGNAL AND CURRENT COMPANY LABELING WARNS AGAINST THE USE OF MONOPOLAR ELECTROCAUTERY (PHYSICIAN¿S IMPLANT MANUAL 9055940-001). DEVICE EVALUATION INDICATED THAT THE IPG PASSED THE VISUAL, ELECTRICAL, PERFORMANCE AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE COMPLAINT OF PREMATURE BATTERY DEPLETION WAS CONFIRMED. THE ANALOG INTEGRATED CIRCUIT (AIC) WAS DAMAGED. THE BATTERY DEPLETION RATE WITH STIMULATION OFF EXCEEDED THE TYPICAL BATTERY DEPLETION RATE. THE AIC DAMAGE RESULTED IN RAPID BATTERY DEPLETION AND CONSEQUENT DIFFICULTY CHARGING THE IPG. ROOT CAUSE OF THE AIC DAMAGE WAS DUE TO ELECTROCAUTERY USE AT A PRIOR SPINE SURGERY. EXPOSING AIC TO HIGH ELECTROMAGNETIC OR VOLTAGE TRANSIENT COULD CAUSE THIS TYPE OF FAILURE (REFERENCE (B)(4)).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO A REVISION DUE TO INABILITY TO CHARGE. A BSN REPRESENTATIVE ANALYZED THE IPG DATABASE AND CONFIRMED PREMATURE BATTERY DEPLETION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO A REVISION DUE TO INABILITY TO CHARGE. A BSN REPRESENTATIVE ANALYZED THE IPG DATABASE AND CONFIRMED PREMATURE BATTERY DEPLETION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO A REVISION DUE TO INABILITY TO CHARGE. A BSN REPRESENTATIVE ANALYZED THE IPG DATABASE AND CONFIRMED PREMATURE BATTERY DEPLETION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48475 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR