BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 5148616 · Received October 14, 2015

    Report

    Report Number
    3006630150-2015-02579
    Event Type
    Malfunction
    Date Received
    October 14, 2015
    Date of Event
    May 13, 2015
    Report Date
    May 13, 2015
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF LEAD SC-2218-30, S/N (B)(4): VISUAL INSPECTION REVEALED THAT THE LEAD WAS CLEANLY CUT APPROXIMATELY 27 CM FROM THE DISTAL END. THE PROXIMAL END OF THE LEAD PORTION WAS NOT RETURNED. ELECTRICAL TESTS COULD NOT BE PERFORMED DUE TO BROKEN CABLES. THE DAMAGE TO THE LEAD IS CONSISTENT WITH DAMAGES DONE DURING THE EXPLANT PROCEDURE AND IT IS NOT CONSIDERED A FAILURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION AND UNDERWENT A LEAD EXPLANT PROCEDURE DUE TO HIGH IMPEDANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679706 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-30 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1