BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 1358044 · Received March 3, 2009

    Report

    Report Number
    3004209178-2009-01483
    Event Type
    Malfunction
    Date Received
    March 3, 2009
    Report Date
    February 5, 2009
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZM
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED SHOCKING / JOLTING SENSATIONS FROM HER DEVICE. TURNING THE STIMULATION DOWN RESULTED IN LOSS OF THERAPEUTIC EFFECT. FURTHER INFORMATION IS BEING REQUESTED FROM THE HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZM MEDTRONIC PUERTO RICO OPERATIONS CO. 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3889| EXPLANTED:| PROGRAMMER: MODEL 3031A| EXTENSION: MODEL 3095