BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 4191442 · Received October 22, 2014

    Report

    Report Number
    3006630150-2014-02387
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SC-1110-02 (SN (B)(4)) DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL, ELECTRICAL, PERFORMANCE AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE SOURCE OF THE COMPLAINT WAS VERIFIED TO BE THE ASSOCIATED LEAD WHOSE WIRES WERE FRACTURED 1 CM FROM THE CLIK ANCHOR SITE. THE IPG WAS VERIFIED TO BE WORKING AS EXPECTED. SC-2218-50 (SN (B)(4)) THE COMPLAINT OF HIGH IMPEDANCES WAS CONFIRMED. VISUAL (MICROSCOPE) AND X-RAY INSPECTION OF THE LEAD REVEALED THAT ALL OF THE CABLES WERE COMPLETELY BROKEN AT THE BENT/KINKED LOCATION OF THE LEAD, APPROXIMATELY 10.22 CM FROM THE DISTAL END. THE BENT/KINKED LOCATION IS 1 CM FROM THE SET SCREW MARK OF THE CLIK ANCHOR. THE COMPLETELY SEVERED CABLES ARE THE REASON FOR THE HIGH IMPEDANCES OBSERVED. THE BROKEN CABLES ARE STILL CONTAINED INSIDE THE LEAD BODY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT¿S LEAD HAD HIGH IMPEDANCES AND LEAD MIGRATION. THE PHYSICIAN SUSPECTED DEVICE MALFUNCTION. DATABASE ANALYSIS REVEALED HIGH IMPEDANCE MEASURES ON ALL CONTACTS AND BATTERY DISCHARGE AND CHARGE PROFILE REVEALED NO ANOMALIES. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE LEADS AND THE IPG WAS REPLACED. THE IPG WAS REPLACED PER PHYSICIAN¿S PREFERENCE SINCE FLUID GOT INTO THE HEADER OF THE IPG AND WAS NOT COMFORTABLE USING IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671044 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention