BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SC-1110-02

    MDR report key: 6598887 · Received May 30, 2017

    Report

    Report Number
    3006630150-2017-02012
    Event Type
    Malfunction
    Date Received
    May 30, 2017
    Date of Event
    December 25, 2015
    Report Date
    February 26, 2016
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767688
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY. IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MED WATCH WILL BE FILED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD FREQUENT AND DIFFICULTY CHARGING THE IPG. IT WAS FOUND OUT THAT THE BATTERY WAS STILL IN HIBERNATION DUE TO THE CHARGING PUCK NOT STAYING IN PLACE WHILE CHARGING. IT WAS ALSO NOTED THAT THE IPG HAD TELEMETRY ERROR. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379860 SC-1110-02 SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA 08714729767688

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR