BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 1080744 · Received July 23, 2008

    Report

    Report Number
    3004209178-2008-04288
    Event Type
    Injury
    Date Received
    July 23, 2008
    Report Date
    June 23, 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
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED A LOSS OF EFFECT AND A BURNING SENSATION AND PAIN IN HER BACK RELATED TO HER DEVICE. THE DEVICE WAS "NOT WORKING". THE DEVICE POCKET INCISION WAS HEALED BUT THE LEAD ACROSS HER SPINE WAS BOTHERING HER; THE SKIN KEEPS OPENING UP AND WON'T HEAL. THE PT FELT SHE MAY HAVE AN INFECTION. THE DEVICE WAS EVENTUALLY TURNED OFF AS THE PT EXPERIENCED ELECTRICAL SHOCKS WHEN IT WAS ON. FURTHER INFO IS BEING REQUESTED FROM THE HCP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED| LEAD MODEL 3889 LOT# V100722| EXPLANTED| PROGRAMMER MODEL 3037 LOT# NJD068096N