BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION SPECTRA®

    MDR report key: 5946919 · Received September 13, 2016

    Report

    Report Number
    3006630150-2016-02533
    Event Type
    Malfunction
    Date Received
    September 13, 2016
    Date of Event
    July 25, 2016
    Report Date
    August 17, 2016
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN CONFIRMED THAT NO DEVICE MALFUNCTION WAS SUSPECTED. IT WAS NOTED THAT THE PATIENT HAD POCKET SITE IRRITATION AND HAD INADEQUATE STIMULATION. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT铠DEVICE WAS NOT WORKING. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S DEVICE WAS NOT WORKING. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597367 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR