BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 3801084 · Received May 8, 2014

    Report

    Report Number
    3006630150-2014-01022
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    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 CHARGE CURRENT SOMETIMES REACHED THE MAXIMUM WHICH INDICATED GOOD ALIGNMENT, BUT THIS OPTIMAL ALIGNMENT WAS NOT CONSISTENT. THE REASON FOR THE ERRATIC COUPLING IS UNKNOWN. BATTERY PROFILE REVEALED A MAXIMUM DEPLETION RATE THAT WAS WITHIN THE EXPECTED RANGE. DEVICE EXHIBITED NORMAL CHARGING AND DISCHARGING CHARACTERISTICS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS CHARGING FREQUENTLY. THE PATIENT UNDERWENT A REVISION WHEREIN THE IPG WAS REPLACED. THE PATIENT WAS DOING WELL AFTER THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS CHARGING FREQUENTLY. THE PATIENT UNDERWENT A REVISION WHEREIN THE IPG WAS REPLACED. THE PATIENT WAS DOING WELL AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277601 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR