BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3073438 · Received April 23, 2013

    Report

    Report Number
    3006630150-2013-00795
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 2, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION INDICATED THAT THE IPG PASSED THE VISUAL, ELECTRICAL AND PERFORMANCE TESTS PERFORMED. THE SOURCE OF THE POCKET PAIN WAS NOT VERIFIED. CURRENT LEAKAGE TESTS AND RESIDUAL GAS ANALYSIS VERIFIED THAT THERE WAS NO LOSS OF ELECTRIC CURRENT OR SPURIOUS SIGNALS INTO THE SURROUNDING TISSUE AS A RESULT OF FAULTY INSULATION. THE MONITORED STIMULATION FOUND THAT THE OUTPUTS WERE CONSISTENT AND AMPLITUDE/PULSE WIDTHS WERE VERIFIED TO BE CORRECT ON ALL ELECTRODES. THE DEVICE PASSED ALL REQUIRED TESTS. THE DEVICE EXHIBITED NORMAL DEVICE CHARACTERISTICS. DEVICE EVALUATION INDICATED THAT THE PADDLE LEAD EXHIBITED CLEAR LEAD BODY CUTS, WIRE EXPOSURES, AND PADDLE DISLODGEMENTS. SINCE THERE WAS NO COMPLAINT OF HIGH IMPEDANCE, AND THE DAMAGE WAS SIMILAR TO THE TYPICAL EXPLANT DAMAGE, IT WAS NOT CONSIDERED A FAILURE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS 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 UNDERWENT AN EXPLANT PROCEDURE DUE TO POCKET SITE PAIN. THE PHYSICIAN SUSPECTED DEVICE MALFUNCTION. THE PATIENT WAS REPORTEDLY DOING WELL AFTER THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO POCKET SITE PAIN. THE PHYSICIAN SUSPECTED DEVICE MALFUNCTION. THE PATIENT WAS REPORTEDLY DOING WELL AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174250 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 22 MO Required Intervention