BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2013497 · Received February 3, 2011

    Report

    Report Number
    3004209178-2011-00862
    Event Type
    Malfunction
    Date Received
    February 3, 2011
    Report Date
    January 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
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED A SHOCKING/JOLTING SENSATION AND PAIN IN THE TESTICLES. THE PT WAS ALSO UNABLE TO ADJUST STIMULATION. THE PT WAS INSTRUCTED ON HOW TO MOVE TO A DIFFERENT GROUP/PROGRAM, AND WAS MORE COMFORTABLE. 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 IMPLANTED:| EXPLANTED:| LEAD: MODEL 3093, LOT# V601604| PROGRAMMER: MODEL 3037, NJD119038N