BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2093973 · Received May 16, 2011

    Report

    Report Number
    3004209178-2011-03537
    Event Type
    Injury
    Date Received
    May 16, 2011
    Date of Event
    February 1, 2011
    Report Date
    April 14, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT FELT STIMULATION FOR A WEEK AFTER THE INITIAL IMPLANT AND THEN HAD NO STIMULATION. THE PT TURNED THE UNIT UP TO AROUND 9 AMPS AND DID NOT GET A RESPONSE. THE HEALTHCARE PROFESSIONAL AND MANUFACTURER'S REP ASSESSED THE DEVICE TOGETHER AND AFTER A THOROUGH REPROGRAMMING SESSION AND MEASUREMENT READING ON HER DEVICE, IT WAS DETERMINED THAT THE DEVICE WAS AT END OF LIFE ON THE BATTERY. FOLLOWING FURTHER QUESTION TO THE PT, IT WAS FOUND THE PT HAD AN MRI DESPITE INSTRUCTION AGAINST THE PROCEDURE. IT WAS FOLLOWING THE MRI THAT THE PT NO LONGER HAD STIMULATION. THE DEVICE WAS REPLACED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention LEAD: MODEL 3093, LOT# V556394| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD114650N