BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 1180186 · Received September 29, 2008

    Report

    Report Number
    3004209178-2008-06191
    Event Type
    Injury
    Date Received
    September 29, 2008
    Date of Event
    October 31, 2007
    Report Date
    September 2, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S STIMULATION HAS GONE DOWN HER LEFT LEG SINCE IMPLANT. SHE HAS NEVER HAD THERAPEUTIC EFFECT. THE PT HAS EXPERIENCED SHOCKING SENSATIONS SINCE IMPLANT. SHOCKING SENSATIONS OCCURRED WHEN SHE WAS AROUND AN ELECTRO-MAGNETIC INTERFERENCE AND POSITION CHANGES. SHE WOULD BE FINE BENDING OVER A TABLE BUT WHEN SHE WOULD STAND UP SHE WOULD GET SHOCKED. THE SHOCKING SENSATION STARTED IN HER TOES AND TRAVELED UP TO THE IMPLANT SITE. SHE FELL LAST WINTER AND THE SHOCKING SENSATIONS HAVE INCREASED. SHE HAD X-RAYS FOR LEAD PLACEMENT AFTER IMPLANT AND AFTER THE FALL. THE PT BELIEVED HER LEAD MOVED. THE IMPLANTABLE NEUROSTIMULATOR WAS AT THE SURFACE OF HER SKIN, "IT USED TO BE DEEPER". THE PT WAS AT HOME. FURTHER INFO IS BEING REQUESTED FROM THE HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MEDTRONIC PUERTO RICO OPERATIONS CO 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED| LEAD MODEL 3093 LOT# V057999| EXPLANTED| PROGRAMMER MODEL 3037 LOT# NJD44924N