BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2172254 · Received July 22, 2011

    Report

    Report Number
    3006630150-2011-01120
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 24, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL, ELECTRICAL, PERFORMANCE AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE COMPLAINT OF TELEMETRY ANOMALY WAS NOT CONFIRMED. DEVICE WAS CHARGED, THEN TESTED WITH MULTIPLE REMOTE CONTROLS AND WAS ABLE TO PERFORM ALL TELEMETRY FUNCTIONS. IN PARTICULAR DEVICE WAS TESTED WHICH MEASURES TELEMETRY FUNCTIONS WITH A TEST REMOTE CONTROL SENDING BOTH LARGE AND NORMAL PACKETS OF DATA. DEVICE EXHIBITS NORMAL TELEMETRY FUNCTIONS. THE COMPLAINT STATED CHARGING WAS ATTEMPTED PRIOR TO TRYING TO LINK. INITIAL ANALYSIS CONFIRMED THAT THE IPG BATTERY WAS COMPLETELY DISCHARGED WHEN RECEIVED IN. IN THIS STATE THE IPG WILL NOT PERFORM TELEMETRY FUNCTIONS WITH A REMOTE CONTROL, AND IS THE REASON THE IPG COULD NOT LINK TO THE REMOTE CONTROL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A LEAD REVISION PROCEDURE, DUE TO INADEQUATE COVERAGE, THE PHYSICIAN CHOSE TO EXPLANT THE PATIENT'S IPG DUE TO SUSPECTED MALFUNCTION. THE PHYSICIAN IMPLANTED THE PATIENT WITH A NEW IPG AND THE PATIENT IS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A LEAD REVISION PROCEDURE, DUE TO INADEQUATE COVERAGE, THE PHYSICIAN CHOSE TO EXPLANT THE PATIENT'S IPG DUE TO SUSPECTED MALFUNCTION. THE PHYSICIAN IMPLANTED THE PATIENT WITH A NEW IPG AND THE PATIENT IS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention