BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 2323604 · Received November 3, 2011

    Report

    Report Number
    3007566237-2011-08969
    Event Type
    Malfunction
    Date Received
    November 3, 2011
    Date of Event
    October 11, 2011
    Report Date
    October 14, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD: MODEL 3093, LOT# V800432, IMPLANTED: 2011 (B)(6), EXPLANTED: UNKNOWN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED INDICATED THAT THERE WAS NO EVENT PAIRED WITH THE ISSUE AND THAT THE PATIENT WAS DOING WELL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STIMULATION WAS INTERMITTENT, BUT THE ISSUE WAS RESOLVED. THE CAUSE WAS NOT PROVIDED. IT WAS LATER REPORTED THAT THE PATIENT EXPERIENCED A HEADACHE WHILE STIMULATION WAS TURNED ON FOLLOWING THE IMPLANT OF A STAGE 1 TRIAL LEAD. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3625

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR