BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 4130431 · Received September 30, 2014

    Report

    Report Number
    3006630150-2014-02226
    Event Type
    Injury
    Date Received
    September 30, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 8, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE EXPLANTED IPG AND LEAD WERE RETURNED. DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL, ELECTRICAL, PERFORMANCE AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE COMPLAINT COULDN'T BE CONFIRMED. THE STIMULATION OUTPUTS WERE MONITORED ON AN OSCILLOSCOPE AND VERIFIED THERE WAS NO RESIDUAL STIMULATION AFTER BEING TURNED OFF BY THE REMOTE CONTROL. THE IPG PASSED ALL THE REQUIRED TESTS AND REVEALED NO ANOMALIES. DEVICE EVALUATION INDICATED THAT THE LEAD PASSED PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE LEAD BODY WAS CUT CLEANLY. BOTH PROXIMAL ENDS AND PADDLE WERE NOT RETURNED. NO OTHER ANOMALIES WERE PRESENT. THE DAMAGE WAS A RESULT OF A TYPICAL EXPLANT PROCEDURE, AND IT WAS NOT CONSIDERED A FAILURE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS EXPLANTED DUE TO THE BATTERY SPINNING IN THE POCKET AND WAS CAUSING DISCOMFORT. THE PHYSICIAN DID NOT SUSPECT ANY DEVICE MALFUNCTION. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-8216-70, SERIAL #: (B)(4), DESCRIPTION: ARTISAN SURGICAL LEAD, 70CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE FOR AN UNKNOWN REASON.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE FOR AN UNKNOWN REASON.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE FOR AN UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608531 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention