BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 5362180 · Received January 12, 2016

    Report

    Report Number
    3006630150-2015-03496
    Event Type
    Injury
    Date Received
    January 12, 2016
    Report Date
    December 3, 2015
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SC-1110-02 (SN (B)(4)): DEVICE EVALUATION INDICATED THAT THE DEVICE PASSED ALL TESTS PERFORMED AND REVEALED NO ANOMALIES. SC-8216-50 (SN (B)(4)): DEVICE EVALUATION INDICATED THAT THE DEVICE PASSED ALL TESTS PERFORMED. VISUAL/X-RAY INSPECTIONS AND IMPEDANCE TEST WERE PERFORMED TO ENSURE THE DEVICE INTEGRITY. NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: 2013. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-8216-50, SERIAL/LOT #: (B)(4), DESCRIPTION: ARTISAN SURGICAL LEAD, 50CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING RINGING IN THE EARS WHEN THE DEVICE IS ACTIVATED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. NO DEVICE MALFUNCTION WAS SUSPECTED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING RINGING IN THE EARS WHEN THE DEVICE IS ACTIVATED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. NO DEVICE MALFUNCTION WAS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20767 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention