BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 1001716 · Received February 15, 2008

    Report

    Report Number
    3004209178-2008-00700
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Report Date
    December 19, 2007
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE HAS NOT BEEN RETURNED TO MEDTRONIC FOR EVALUATION. IF FURTHER INFORMATION IS RECEIVED OR THE DEVICE RETURNED, A FOLLOW-UP MEDWATCH REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT WHILE CHRISTMAS SHOPPING, SHE SET OFF ALARMS WHEN GOING THROUGH THEFT DETECTORS AT SEVERAL STORES. SHE STATES, THAT SHE IS NOW FEELING SORE AT HER INS SITE. 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