BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 1890972 · Received October 29, 2010

    Report

    Report Number
    3004209178-2010-08640
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    August 11, 2010
    Report Date
    October 4, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PT HAD A FLUID SHORT AND THE ENTIRE SYSTEM HAD TO BE REPLACED. THE PT WAS NOTED IN GOOD CONDITION. A FOLLOW UP APPOINTMENT WITH THE HCP AND THE COMPANY REP WAS SCHEDULED. IT WAS SUBSEQUENTLY REPORTED THE PT'S SYSTEM WAS REPLACED, BUT NOT WITH ANOTHER INTER-STIM DEVICE. THE SURGEON USED A SYNERGY DEVICE. THE SURGEON DECIDED TO LEAVE THE PT'S OLD LEAD IMPLANTED. THEY "TESTED THE LEAD IN THE OPERATING ROOM, AND DID NOT GET ANY MOTOR RESPONSES WHICH LEAD THEM TO BELIEVE THAT THE LEAD 'SHIFTED.' THE SURGEON IMPLANTED TWO ADDITIONAL LEADS FOR THE NEW DEVICE, ONE FOR EACH SIDE OF THE SACRUM. THE REP CLARIFIED THAT THERE WAS NO FLUID SHORT PRESENT. THE DEVICE WAS DEPLETED DUE TO NORMAL USAGE. THE PT WAS NOTED AS SATISFIED WITH HER NEW IMPLANT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR EXPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 3031A, LOT# NGM011023P| EXTENSION: MODEL 3095, LOT# NAH010090V| LEAD: MODEL 3889, LOT# J0348932V| IMPLANTED: