BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 4191021 · Received October 21, 2014

    Report

    Report Number
    3006630150-2014-02388
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 26, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL, ELECTRICAL, PERFORMANCE AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE COMPLAINT WAS NOT VERIFIED. THE DEVICE HAD BEEN IN HIBERNATION, AND IT WAS UNABLE TO COMMUNICATE WITH A REMOTE CONTROL. THE DEVICE WAS ABLE TO COMMUNICATE WITH A REMOTE CONTROL AFTER BEING CHARGED. THE MONITORED STIMULATION ON AN OSCILLOSCOPE FOUND THE OUTPUTS WERE CONSISTENT AND CORRECT ON ALL ELECTRODES. IMPEDANCE READINGS WERE WITHIN THE EXPECTED RANGE. THE IPG PASSED ALL THE REQUIRED TESTS AND REVEALED NO ANOMALIES.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG COULD NOT COMMUNICATE WITH THE REMOTE CONTROL AND WAS NOT PROVIDING STIMULATION. THE PATIENT UNDERWENT AN IPG REPLACEMENT. DEVICE MALFUNCTION WAS SUSPECTED. THE PATIENT WAS REPORTEDLY DOING WELL POST OPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG COULD NOT COMMUNICATE WITH THE REMOTE CONTROL AND WAS NOT PROVIDING STIMULATION. THE PATIENT UNDERWENT AN IPG REPLACEMENT. DEVICE MALFUNCTION WAS SUSPECTED. THE PATIENT WAS REPORTEDLY DOING WELL POST OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670121 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR