BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 3201932 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-02182
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    June 10, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A PNE (PERIPHERAL NERVE EVALUATION) STAGE TODAY ((B)(6)-2013). WHILE PLACING THE 3065U, AT MAX OUTPUT, THE PATIENT STOPPED BREATHING AND THEY HAD TO REMOVE ALL SYSTEM. THEY FLIPPED THE PATIENT OVER AND HAD TO RESUSCITATE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IN MFR # 3007566237-2013-02204 THE FOLLOWING INFORMATION WAS REPORTED: "IT WAS REPORTED THAT THE TRIAL PATIENT STOPPED BREATHING DURING A PERCUTANEOUS NERVE EVALUATION (PNE) CASE. 'THEY' HAD PLACED BILATERAL NEEDLES IN S3 AND WERE GETTING READY TO PLACE THE LEADS WHEN IT WAS INDICATED 'THEY' NEEDED TO FLIP THE PATIENT AS THE PATIENT STOPPED BREATHING DUE TO ANESTHESIA. 'THEY' REVIVED THE PATIENT AND HE WAS DOING FINE AT THE TIME OF THE REPORT. ANOTHER PNE WAS TENTATIVELY PLANNED FOR (B)(6) 2013." ADDITIONAL REVIEW INDICATES THIS INFORMATION PERTAINS TO THIS MANUFACTURER¿S REPORT. ANY ADDITIONAL INFORMATION RELATED TO THE PATIENT STOPPING BREATHING DURING THE PROCEDURE ISSUE EVENT WILL BE REPORTED IN THIS REPORT. ADDITIONAL INFORMATION REPORTED INDICATED THAT THERE WERE NO LONG TERM COMPLICATIONS WITH THE PATIENT. IT WAS STATED THAT HE WAS SCHEDULED FOR A BASIC EVALUATION TWO WEEKS AFTER THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302871 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3065USC N380338

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R