BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 2963717 · Received February 15, 2013

    Report

    Report Number
    3006630150-2013-00233
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Report Date
    January 17, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    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, AND INDICATES GOOD ALIGNMENT, BUT THIS OPTIMAL ALIGNMENT WAS NOT CONSISTENT. THE REASON FOR THE ERRATIC COUPLING IS UNKNOWN. BATTERY PROFILE REVEALED A MAXIMUM DEPLETION RATE PER DAY, WHICH IS WITHIN THE EXPECTED RANGE. DEVICE EXHIBITS NORMAL CHARGING AND DISCHARGING CHARACTERISTICS. 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 PER CIS DEPARTMENT COMMUNICATION PROTOCOL LOOP TEST WHICH MEASURES TELEMETRY FUNCTIONS AT DISTANCES FROM A TEST REMOTE CONTROL SENDING BOTH LARGE AND NORMAL PACKETS OF DATA. DEVICE EXHIBITS NORMAL TELEMETRY FUNCTIONS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING CHARGING AND COMMUNICATION DIFFICULTY BETWEEN THE REMOTE CONTROL AND THE IPG AFTER A NON-DEVICE RELATED SURGERY. THE PATIENT UNDERWENT AN IPG REPLACEMENT AND WAS DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING CHARGING AND COMMUNICATION DIFFICULTY BETWEEN THE REMOTE CONTROL AND THE IPG AFTER A NON-DEVICE RELATED SURGERY. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING CHARGING AND COMMUNICATION DIFFICULTY BETWEEN THE REMOTE CONTROL AND THE IPG AFTER A NON-DEVICE RELATED SURGERY. THE PATIENT UNDERWENT AN IPG REPLACEMENT AND WAS DOING WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68510 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1