BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 1213794 · Received October 22, 2008

    Report

    Report Number
    3004209178-2008-06789
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Report Date
    September 23, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S SYMPTOMS WERE SIGNIFICANTLY IMPROVED FOR THE FIRST TWO MONTHS AFTER IMPLANT. SINCE THEN THE PATIENT HAS FELT SHOCKING SENSATIONS APPROXIMATELY EVERY 15 TO 35 SECONDS. FURTHER INFORMATION IS BEING REQUESTED FROM THE HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 LEAD: MODEL 3093| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 3037