BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 4686432 · Received April 13, 2015

    Report

    Report Number
    3006630150-2015-00864
    Event Type
    Malfunction
    Date Received
    April 13, 2015
    Date of Event
    March 20, 2015
    Report Date
    March 20, 2015
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-8216-50, SERIAL #: (B)(4), DESCRIPTION: ARTISAN SURGICAL LEAD, 50CM.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE DISLODGE CONTACT AND THE PORTION OF A SILICONE MATERIAL MISSING FROM THE CLICK ANCHOR WERE REMOVED FROM THE PATIENT¿S BODY ACCORDING TO THE POST-OPERATIVE NOTES.

    Additional Manufacturer Narrative · 1

    THE SOURCE OF THE COMPLAINT REGARDING THE IMPEDANCE ANOMALY WAS VERIFIED TO BE THE ASSOCIATED PADDLE LEAD. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-4316 LOT #: 15418722 DESCRIPTION: NEXT GENERATION ANCHOR KIT-STERILE SC-1110-02 (SN (B)(4)) DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL, ELECTRICAL, PERFORMANCE AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE COMPLAINT REGARDING THE CHARGING ISSUE WAS NOT VERIFIED. THE DEVICE WAS CAPABLE OF BEING CHARGED FULLY UNDER A PROPER CHARGING METHOD. IN THE LAB, THE IPG WAS SUCCESSFULLY CHARGED TO FULL CAPACITY IN ONE CYCLE. THIS RESULT ATTESTED THAT THE DEVICE WAS CAPABLE OF BEING CHARGED FULLY UNDER A PROPER CHARGING METHOD. THE BATTERY DEPLETION RATE AND QUIESCENT CURRENT MEASURED NORMAL. THE DEVICE EXHIBITED NORMAL DEVICE CHARACTERISTICS. SC-8216-50 (SN (B)(4)) DEVICE EVALUATION INDICATED THAT THE LEAD PASSED MECHANICAL TEST PERFORMED. THE COMPLAINT WAS CONFIRMED. SIX CABLES WERE FRACTURED AT THE BENT/KINKED SECTION OF THE LEAD BODY, 1 CM FROM THE CLIK ANCHOR SET SCREW MARK. THERE WERE NO EXPOSED CABLES. IN ADDITION, THE PADDLE HAD A DISLODGED ELECTRODE. SC-4316 (LN 15418722) A PORTION OF THE SILICONE MATERIAL WAS MISSING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DIFFICULTY CHARGING THE IPG AND WAS EXPERIENCING INADEQUATE STIMULATION DUE TO HIGH IMPEDANCES NOTED ON THE LEAD. THE PHYSICIAN WAS NOT SURE IF THERE WAS DEVICE MALFUNCTION. THE PATIENT UNDERWENT A REPLACEMENT OF THE ENTIRE SYSTEM. THE PATIENT WAS REPORTEDLY DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DIFFICULTY CHARGING THE IPG AND WAS EXPERIENCING INADEQUATE STIMULATION DUE TO HIGH IMPEDANCES NOTED ON THE LEAD. THE PHYSICIAN WAS NOT SURE IF THERE WAS DEVICE MALFUNCTION. THE PATIENT UNDERWENT A REPLACEMENT OF THE ENTIRE SYSTEM. THE PATIENT WAS REPORTEDLY DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DIFFICULTY CHARGING THE IPG AND WAS EXPERIENCING INADEQUATE STIMULATION DUE TO HIGH IMPEDANCES NOTED ON THE LEAD. THE PHYSICIAN WAS NOT SURE IF THERE WAS DEVICE MALFUNCTION. THE PATIENT UNDERWENT A REPLACEMENT OF THE ENTIRE SYSTEM. THE PATIENT WAS REPORTEDLY DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244367 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR