BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 3202596 · Received July 2, 2013

    Report

    Report Number
    3006630150-2013-01364
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 20, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN BELIEVED THAT THE IPG DID NOT WORKED DUE TO THE PATIENT'S PREVIOUS NON-DEVICE RELATED SURGERIES WHERE IT WAS NOT KNOWN IF ELECTROCAUTERY WAS USED. DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE COMPLAINT WAS CONFIRMED. WHEN RECEIVED IN, THE DEVICE HAD NO WAKE UP SIGNAL AND IT APPEARED THE BATTERY WAS DEPLETED. DEVICE WAS CHARGED 3 CYCLES IN AN ATTEMPT TO BRING IT OUT OF HIBERNATION, BUT WAS UNSUCCESSFUL. IT WAS DETERMINED THAT THE ANALOG INTEGRATED CIRCUIT HAD AN INTERNAL SHORT(S) RESULTING IN EXCESSIVE CURRENT DRAIN OF THE BATTERY. THE DAMAGE DONE TO THE ANALOG INTEGRATED CIRCUIT-U1 RESULTED IN THE INABILITY TO CHARGE THE IPG OUT OF RESET MODE AND REGAIN TELEMETRY FUNCTIONS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG WAS UNABLE TO CHARGE AND WOULD NOT LINK WITH THE REMOTE CONTROL. THE PATIENT WILL UNDERGO A BATTERY REPLACEMENT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG WAS UNABLE TO CHARGE AND WOULD NOT LINK WITH THE REMOTE CONTROL. THE PATIENT WILL UNDERGO A BATTERY REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301171 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR