BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 4791728 · Received May 22, 2015

    Report

    Report Number
    3006630150-2015-01299
    Event Type
    Injury
    Date Received
    May 22, 2015
    Date of Event
    March 4, 2015
    Report Date
    May 4, 2015
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2218-70, SERIAL #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 70CM; MODEL #: SC-4316, LOT #: 16428541, DESCRIPTION: NEXT GENERATION ANCHOR KIT-STERILE. SC- 2218-50 (SN (B)(4)) THE COMPLAINT WAS CONFIRMED. VISUAL INSPECTION REVEALED THE LEAD BODIES HAD PRONOUNCED KINKS APPROXIMATELY 18 CM FROM THE DISTAL END, WHERE THE LEADS APPEAR TO HAVE BEEN SUTURED. ALL CABLES REPORTED BROKEN WERE BROKEN/SEVERED AT THIS SPOT. THE FRACTURE SITES ARE 1 CM FROM THE CLIK ANCHOR SETSCREW MARKS. THIS APPEARS TO HAVE BEEN CAUSED BY FATIGUE POSSIBLY COUPLED WITH POSTURAL CHANGES/MOVEMENTS. THE COMPLETELY SEVERED CABLES ARE THE REASON FOR THE HIGH IMPEDANCES OBSERVED DURING TESTING AND THE PATIENT'S LACK OF STIMULATION. THERE ARE NO EXPOSED CABLES. SC-2218-70 (SN (B)(4)) THE COMPLAINT WAS CONFIRMED. VISUAL INSPECTION REVEALED THE LEAD BODIES HAD PRONOUNCED KINKS APPROXIMATELY 18 CM FROM THE DISTAL END, WHERE THE LEADS APPEAR TO HAVE BEEN SUTURED. ALL CABLES REPORTED BROKEN WERE BROKEN/SEVERED AT THIS SPOT. THE FRACTURE SITES ARE 1 CM FROM THE CLIK ANCHOR SETSCREW MARKS. THIS APPEARS TO HAVE BEEN CAUSED BY FATIGUE POSSIBLY COUPLED WITH POSTURAL CHANGES/MOVEMENTS. THE COMPLETELY SEVERED CABLES ARE THE REASON FOR THE HIGH IMPEDANCES OBSERVED DURING TESTING AND THE PATIENT'S LACK OF STIMULATION. THERE ARE NO EXPOSED CABLES. SC-4316 (LN 16428541) DEVICE EVALUATION INDICATED THAT THE CLIK ANCHOR PASSED VISUAL AND PHOTOGRAPHIC TESTS PERFORMED. ANCHORS EXHIBIT NORMAL DEVICE CHARACTERISTICS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING DEVICE ANALYSIS, ONE OF THE PATIENT¿S LEADS HAD PRONOUNCED KINKS AND ALL CABLES WERE BROKEN OR SEVERED. IT WAS ALSO REPORTED THAT THE PATIENT WAS EXPERIENCING LACK OF STIMULATION AFTER A FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336590 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention