BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 2241070 · Received August 17, 2011

    Report

    Report Number
    3004209178-2011-06502
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Report Date
    July 28, 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
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT COULD NOT FEEL STIMULATION. THE PT HAD FALLEN ON HER BACK/BUTTOCK AND HIT HER HEAD ON A CABINET APPROXIMATELY ONE MONTH PRIOR TO REPORT, AND HAD BEEN IN THE HOSPITAL FOR TWO DAYS TO RECOVER. THE PT HAD NOT FELT STIMULATION SINCE THE INCIDENT, BUT COULD NOT FULLY REMEMBER. IT WAS NOTED THAT THE PT COULD FEEL STIMULATION BETTER WITH HER PREVIOUS DEVICE THAN SHE COULD WITH THE NEW ONE. BATTERY VOLTAGE WAS AT 5.4 VOLTS. THE DEVICE WAS SWITCHED TO A DIFFERENT PROGRAM AND STIMULATION WAS ADJUSTED FROM 0.0V TO 4.3V AND THE PT COULD FEEL STIMULATION "BETWEEN HER LEGS." ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR IMPLANTED:| LEAD: MODEL 3093, LOT# V649839| PROGRAMMER: MODEL 3037, LOT# NJD124364N| IMPLANTED:| EXTENSION: MODEL 3095, LOT# NAH047960V| EXPLANTED:| EXPLANTED: