BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2113832 · Received May 17, 2011

    Report

    Report Number
    3004209178-2011-03609
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    March 1, 2011
    Report Date
    April 19, 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
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELL (B)(6) AND STATED THE DEVICE DIDN'T WORK ANYMORE. THE PATIENT WENT TO THE PHYSICIAN AND AN X-RAY SHOWED THAT THE LEAD HAD MOVED. 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 II EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR LEAD: MODEL 3093, LOT# V557158| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD121942N