BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2946110 · Received February 6, 2013

    Report

    Report Number
    3004209178-2013-01367
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Report Date
    January 25, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-28, LOT# V621112, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. IT WAS NOTED THAT THE PATIENT WAS "NOT HAVING THAT BIG OF A PROBLEM YET." IT WAS FURTHER NOTED THAT THE PATIENT THOUGHT THERE WAS SOMETHING WRONG WITH THEIR DEVICE AND THAT THEY DID NOT FEEL STIMULATION. IT WAS FURTHER REPORTED THAT THE PATIENT WAS GETTING THE POOR COMMUNICATION SCREEN ON HER PROGRAMMER.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT RECEIVED ASSISTANCE AND HER CONCERNS WERE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50303 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1