BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1983906 · Received February 7, 2011

    Report

    Report Number
    3006630150-2011-00151
    Event Type
    Injury
    Date Received
    February 7, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 13, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A RETURNED PRODUCT ANALYSIS INDICATED THAT THE COMPLAINTS OF POCKET DISCOMFORT AND DIFFICULTY CHARGING THE IPG WERE NOT VERIFIED. UPON RECEIVING, THE IPG WAS DEPLETED COMPLETELY, AND IT WAS CHARGED UP IN ONE CYCLE AND WAS LINKED WITH A TEST REMOTE CONTROL WITHOUT ANY DISCREPANCIES. THE BATTERY CHARGE PROFILE INDICATES THAT THERE WAS NO CHARGE ATTEMPTS PRIOR TO THE EXPLANT PROCEDURE, SUGGESTING THAT THE DEVICE HAD BEEN PERHAPS DEPLETED AND WAS UNABLE TO LINK. THE CURRENT LEAKAGE TEST RESULT INDICATED THAT THE AMOUNT OF CURRENTS BETWEEN THE IPG CASE TO ELECTRODES WAS SO MINUSCULE, IT COULD NOT BE A SOURCE OF THE POCKET DISCOMFORT. DAILY BATTERY DEPLETION RATE WITH STIMULATION TURNED ON WAS VERIFIED TO BE NORMAL.

    Description of Event or Problem · 1

    A REPORT WAS REC'D THAT THE PT UNDERWENT A POCKET REVISION DUE TO POCKET SITE DISCOMFORT. THE POCKET WAS RELOCATED FROM THE BUTTOCKS AREA TO THE WAISTLINE. THE IPG WAS REPLACED BECAUSE IT HAD NOT BEEN CHARGED PRIOR TO THE REVISION AND INTRA-OPERATIVE TESTING COULD NOT BE PERFORMED ON THE IPG. THE PT WAS DOING FINE AFTER THE POCKET REVISION PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT A POCKET REVISION DUE TO POCKET SITE DISCOMFORT. THE POCKET WAS RELOCATED FROM THE BUTTOCKS AREA TO THE WAISTLINE. THE IPG WAS REPLACED BECAUSE IT HAD NOT BEEN CHARGED PRIOR TO THE REVISION AND INTRA-OPERATIVE TESTING COULD NOT BE PERFORMED ON THE IPG. THE PATIENT WAS DOING FINE AFTER THE POCKET REVISION 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 UNK Required Intervention