BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3474998 · Received November 18, 2013

    Report

    Report Number
    3006630150-2013-02542
    Event Type
    Injury
    Date Received
    November 18, 2013
    Date of Event
    October 24, 2013
    Report Date
    October 24, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2218-70, SERIAL/LOT #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 70CM.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION INDICATED THAT THE IPG PASSED THE VISUAL, ELECTRICAL, PERFORMANCE AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE COMPLAINT OF THE ELECTRICAL SURGE COULD NOT BE DUPLICATED ON THE TEST BENCH. SINCE ONE OF THE RETURNED LEADS EXPOSED SUBSTANTIAL DAMAGES, THE IPG WAS INVESTIGATED WITH KNOWN GOOD LEADS. THE MONITORED STIMULATION ON AN OSCILLOSCOPE FOUND THAT THE OUTPUTS WERE CONSISTENT AND AMPLITUDE/PULSE WIDTHS WERE VERIFIED TO BE CORRECT ON ALL THE ELECTRODES. CURRENT LEAKAGE TESTS AND RESIDUAL GAS ANALYSIS VERIFIED NO LOSS OF ELECTRIC CURRENT INTO THE SURROUNDING TISSUE AS A RESULT OF FAULTY INSULATION. THE IPG PASSED ALL THE REQUIRED TESTS AND REVEALED NO ANOMALIES. DEVICE EVALUATION INDICATED THAT THE LEAD (SN (B)(4)) PASSED THE VISUAL, ELECTRICAL AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. VISUAL AND X-RAY INSPECTIONS WERE PERFORMED TO ENSURE THE DEVICE INTEGRITY. IMPEDANCE MEASUREMENTS WERE WITHIN THE NORMAL RANGE. NO ANOMALIES WERE FOUND. DEVICE EVALUATION INDICATED THAT THE LEAD (SN 339578) WAS CUT DURING THE EXPLANT PROCEDURE, AND THE PROXIMAL END WAS NOT RETURNED. SINCE THERE WAS NO COMPLAINT REGARDING AN IMPEDANCE ANOMALY, THE DAMAGE WAS CONSIDERED PROCEDURE-RELATED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD SHARP PAINS WHEN TURNING ON THE STIMULATOR. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE LEAD AND THE IPG WERE EXPLANTED AND DID WELL POSTOPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD SHARP PAINS WHEN TURNING ON THE STIMULATOR. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE LEAD AND THE IPG WERE EXPLANTED AND DID WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595814 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention