BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2061981 · Received April 6, 2011

    Report

    Report Number
    3004209178-2011-02644
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 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
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS EXPERIENCING A LOSS OF THERAPEUTIC EFFECT WITH LOSS OF BLADDER CONTROL; THEY WERE URINATING EVERY HOUR. THE EVENT OCCURRED FOLLOWING AN IMPLANT AND FOLLOWING A FALL. THE PT WAS HAVING SYMPTOMS PRIOR TO THE FALL, BUT THEN HE HAD A BAD FALL ON THE ICE WHICH WAS ON THE OPPOSITE SIDE OF THE IMPLANT. ADDITIONAL INFO WAS REQUESTED.

    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 68 YR LEAD: MODEL 3889, LOT# V391132| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD100417N| IMPLANTED:| EXPLANTED: