BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2103014 · Received May 25, 2011

    Report

    Report Number
    3006630150-2011-00753
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 3, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL # SC-2218-70 (B)(4) DESCRIPTION: ST LINEAR LEAD, 70CM WITH PRE-LOADED 0.014 INCH STYLET

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE. DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL, ELECTRICAL, AND PERFORMANCE TESTS PERFORMED. THE DEVICE OUTPUT WAS MONITORED FOR EXCESSIVE LEAKAGE CURRENT OR SPURIOUS SIGNALS IN A SALINE SOLUTION, WHILE PROGRAMMED TO THE PATIENT'S LATEST SETTING. NO DISCREPANCIES WERE IDENTIFIED. DEVICE STIMULATION AMPLITUDE AND TIMING WAS MONITORED FOR ERRORS. NO INTERMITTENT ANOMALIES WERE NOTED IN THE OUTPUT. THE DEVICE EXHIBITS NORMAL DEVICE CHARACTERISTICS. THEREFORE, THE REPORTED COMPLAINT OF THE IPG CAUSING PAIN AT THE POCKET SITE WAS NOT DUPLICATED OR CONFIRMED. THE DAMAGE TO THE LEADS WAS CONSISTENT WITH DAMAGES DONE DURING THE EXPLANT PROCEDURE AND ARE NOT CONSIDERED A FAILURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO AN EXPLANT OF HIS ENTIRE SYSTEM DUE TO PAIN AT THE IPG SITE AND BECAUSE OF INADEQUATE THERAPY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO AN EXPLANT OF HIS ENTIRE SYSTEM DUE TO PAIN AT THE IPG SITE AND BECAUSE OF INADEQUATE THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention