BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 2863179 · Received December 10, 2012

    Report

    Report Number
    3006630150-2012-02272
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 16, 2012
    Report Date
    November 16, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-3138-35, SERIAL #: (B)(4), DESCRIPTION: SCS PHIII EXT 35CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE 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 MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG WAS DEAD AND UNABLE TO CHARGE. DATABASE REVEALED THAT THERE WAS SOME OVERHEATING BUT NO PREMATURE BATTERY DEPLETION NOTED. THE PATIENT UNDERWENT POCKET REVISION WHEREIN THE IPG WAS REPLACED PER PHYSICIAN'S PREFERENCE. NO MALFUNCTION SUSPECTED. THE PHYSICIAN DISCOVERED DURING THE REVISION THAT THE LEAD AT THE IPG SITE WAS TWISTED, WHICH WAS CAUSED BY THE PATIENT TWIRLING THE BATTERY. THE PATIENT WAS REPORTEDLY DOING FINE FOLLOWING THE PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR