BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 3133840 · Received May 29, 2013

    Report

    Report Number
    3006630150-2013-01073
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    February 28, 2013
    Report Date
    May 2, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN IPG REPLACEMENT. IT WAS IN THE LEAD PORT WHERE A COUPLE OF CONTACTS WERE OUT. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE. 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-3354-25, SERIAL/LOT #: (B)(4), DESCRIPTION: W4 SPLITTER 2X4-25 CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT¿S SYSTEM WAS DISPLAYING HIGH IMPEDANCES. THE PHYSICIAN IS UNSURE IF THE HIGH IMPEDANCES ARE BEING CAUSED BY THE IPG OR THE SPLITTERS. THE PATIENT¿S SYSTEM WILL BE REPLACED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT¿S SYSTEM WAS DISPLAYING HIGH IMPEDANCES. THE PHYSICIAN IS UNSURE IF THE HIGH IMPEDANCES ARE BEING CAUSED BY THE IPG OR THE SPLITTERS. THE PATIENT¿S SYSTEM WILL BE REPLACED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT¿S IPG WAS NOT GETTING GOOD IMPEDANCE CHECK. THE PATIENT WILL UNDERGO A REVISION TO REPLACE THE IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235827 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR