BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION SPECTRA®

    MDR report key: 4211958 · Received October 29, 2014

    Report

    Report Number
    3006630150-2014-02519
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 7, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WILL BE NO FURTHER COURSE OF ACTION. IT IS INDICATED THAT THE DEVICE 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 MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG WAS REPLACED DUE TO NON-FUNCTIONING. THE PATIENT WAS REPORTEDLY DONG WELL POST OPERATIVELY.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION INDICATED THAT THE COMPLAINT OF CHARGING/TELEMETRY ANOMALY WAS CONFIRMED. DEVICE WAS CHARGED IN AN ATTEMPT TO BRING IT OUT OF HIBERNATION, BUT WAS UNSUCCESSFUL. WHEN THE DEVICE WAS CUT OPEN, IT WAS EXTERNALLY POWERED AND SLEEP CURRENT WAS OUT OF THE EXPECTED RANGE, AND INDICATED THE DEVICE CURRENT DRAIN WAS TOO SEVERE TO POWER THE IPG ELECTRONICS. IT WAS DETERMINED THAT THE MASTER APPLICATION-SPECIFIC INTEGRATED CIRCUIT (ASIC) U2 HAD AN INTERNAL SHORT(S) RESULTING IN EXCESSIVE CURRENT DRAIN OF THE BATTERY. THE DAMAGE DONE TO THE MASTER ASIC-U2 RESULTED IN THE INABILITY TO CHARGE THE IPG AND/OR GET IT OUT OF RESET MODE, REGAIN TELEMETRY FUNCTIONS AND TURN ON STIMULATION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG COULD NOT ESTABLISH COMMUNICATION. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG COULD NOT ESTABLISH COMMUNICATION. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG COULD NOT ESTABLISH COMMUNICATION. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG COULD NOT ESTABLISH COMMUNICATION. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693011 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR