BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 2930759 · Received January 28, 2013

    Report

    Report Number
    3006630150-2013-00154
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 10, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL, ELECTRICAL, PERFORMANCE AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE COMPLAINT OF DIFFICULTY CHARGING WAS NOT CONFIRMED. CHARGE PROFILE REVEALED VARIOUS TIMES OF ERRATIC COUPLING/POOR ALIGNMENT OF THE CHARGER TO THE IPG. THE REASON FOR THE ERRATIC COUPLING IS UNKNOWN. BATTERY PROFILE REVEALED A MAXIMUM DEPLETION RATE OF 11MV PER DAY, WHICH IS WITHIN THE EXPECTED RANGE. DEVICE EXHIBITS NORMAL CHARGING AND DISCHARGING CHARACTERISTICS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE DUE TO INABILITY TO HOLD ITS CHARGE. THE PATIENT RECEIVED GOOD STIMULATION COVERAGE POSTOPERATIVELY. THE PATIENT HAD A PREVIOUS NONDEVICE RELATED SURGERY WHEREIN ELECTROCAUTERY WAS USED. MONOPOLAR ELECTROCAUTERY IS A KNOWN SOURCE OF HIGH VOLTAGE TRANSIENT SIGNAL AND CURRENT COMPANY LABELING WARNS AGAINST THE USE OF MONOPOLAR ELECTROCAUTERY (PHYSICIAN'S IMPLANT MANUAL 9055940-001).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE DUE TO INABILITY TO HOLD ITS CHARGE. THE PATIENT RECEIVED GOOD STIMULATION COVERAGE POSTOPERATIVELY. THE PATIENT HAD A PREVIOUS NON-DEVICE RELATED SURGERY WHEREIN ELECTROCAUTERY WAS USED. MONOPOLAR ELECTROCAUTERY IS A KNOWN SOURCE OF HIGH VOLTAGE TRANSIENT SIGNAL AND CURRENT COMPANY LABELING WARNS AGAINST THE USE OF MONOPOLAR ELECTROCAUTERY (PHYSICIAN'S IMPLANT MANUAL 9055940-001).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37524 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR