BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 1971026 · Received January 6, 2011

    Report

    Report Number
    3004209178-2011-00118
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 30, 2010
    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
    MI, 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 SHOCK/JOLTING SENSATION AND A LOSS OF THERAPEUTIC EFFECT. THE PT HAD FALLEN ON THE DEVICE A "COUPLE NIGHTS AGO." WHEN THE PT WENT TO INCREASE THE STIMULATION, THE PT WAS "ELECTROCUTED WITH THEIR LEGS AND ARMS FLUNG BACK." IT OCCURRED WHILE OPERATING A TV REMOTE CONTROL. THERE WAS BRUISING AT THE DEVICE SITE, BUT NO SWELLING. ADDITIONAL INFO HAS BEEN 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 27 YR PROGRAMMER: MODEL 3037, LOT# NJD100750N| LEAD: MODEL 3889, LOT# V399340| EXPLANTED:| IMPLANTED: