BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2193623 · Received July 14, 2011

    Report

    Report Number
    3004209178-2011-05427
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    June 19, 2011
    Report Date
    June 20, 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
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT, WITH A LOSS OF BLADDER CONTROL. THE PATIENT WAS USING PROGRAM 3 AT 5.1 VOLTS, AND THEN INCREASED THE STIMULATION TO 5.9 VOLTS. NO INFORMATION WAS PROVIDED RELATED TO THE PATIENT'S OUTCOME. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION 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 91 YR PROGRAMMER: MODEL 3037, LOT# NJD085355N| IMPLANTED:| LEAD: MODEL 3093, LOT# V238901| EXPLANTED: