BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 4153460 · Received October 8, 2014

    Report

    Report Number
    3006630150-2014-02299
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 10, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE IPG WAS REPLACED DUE TO MALFUNCTION. DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL, PERFORMANCE AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE COMPLAINT WAS NOT VERIFIED. WHEN ALL THE STIMULATIONS WERE TURNED OFF, THE BATTERY DEPLETION RATE AND SLEEP CURRENT WERE WITHIN THE NORMAL RANGE. THE DEVICE EXHIBITED NORMAL DEVICE CHARACTERISTICS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT¿S IPG WAS NOT HOLDING ITS CHARGE. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE AND DID WELL POSTOPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT¿S IPG WAS NOT HOLDING ITS CHARGE. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE AND DID WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630892 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1