BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2670056 · Received July 26, 2012

    Report

    Report Number
    3004209178-2012-06095
    Event Type
    Malfunction
    Date Received
    July 26, 2012
    Report Date
    June 28, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3093-33, LOT# V833270, 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 EXPERIENCED A LOSS OF THERAPEUTIC EFFECT FROM THE IMPLANTABLE NEUROSTIMULATOR (INS) WHICH BEGAN (B)(6). IT WAS NOTED THAT THE PATIENT MAY HAVE GONE THROUGH A SECURITY SCANNER BUT IT WAS UNCLEAR AS TO THE RELATIONSHIP TO THIS EVENT. IT WAS NOTED THAT THE PATIENT WAS ON PROGRAM 2 BUT WAS NOT HELPING AND DID NOT INCREASE THE STIMULATION BECAUSE IT WAS TOO PAINFUL. THE PATIENT DID HAVE AN APPOINTMENT SCHEDULED FOR (B)(6) 2012, WITH HIS PHYSICIAN. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1