BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 4623121 · Received March 23, 2015

    Report

    Report Number
    3007566237-2015-00677
    Event Type
    Malfunction
    Date Received
    March 23, 2015
    Date of Event
    February 22, 2015
    Report Date
    February 25, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR OFF-LABEL INDICATION. THE INDICATION THE DEVICE WAS USED FOR WAS MHY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTENSION HAD AN ¿ANOMALY¿ AND WAS DEFECTIVE. THE DEVICE WAS OPENED BUT WAS NOT USED WITH THE PATIENT. THERE WAS NO HEALTH HAZARD TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193478 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3550-05

    Patients

    Seq Age Sex Outcome Treatment
    1