BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2894120 · Received January 3, 2013

    Report

    Report Number
    3004209178-2013-00074
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Report Date
    December 10, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-33, LOT # VA0364U, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STIMULATION WAS TURNING OFF. THE REPORTER STATED THAT THE PATIENT WAS AT A RETAIL STORE RECENTLY AND FOUND THAT WHEN SHE RETURNED HOME, THE DEVICE WAS OFF. IT WAS REPORTED THAT THE PATIENT BELIEVED THAT THE SECURITY DEVICES AT THE STORE TURNED HER DEVICE OFF. THE PATIENT DIDN'T SEE ANY MESSAGES ON THE PROGRAMMER WHEN TURNING THE DEVICE BACK ON, ALTHOUGH THE PATIENT DIDN'T TURN IT ON HERSELF SO SHE DIDN'T KNOW EXACTLY WHAT WAS ON THE SCREEN. IT WAS REPORTED THAT THE PATIENT WAS 100 PERCENT SURE THAT THE DEVICE WAS ON WHEN SHE ENTERED THE STORE AND WAS OFF WHEN SHE HAD THE DEVICE CHECKED AFTER THAT. IT WAS NOTED THAT THE DEVICE WAS RECENTLY IMPLANTED. 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
    2368 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1