BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2081062 · Received April 14, 2011

    Report

    Report Number
    3004209178-2011-02828
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 28, 2011
    Report Date
    April 5, 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
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A LOSS OF THERAPEUTIC EFFECT SINCE (B)(6). ALL 4 PROGRAMS WERE TRIED UP TO THEIR MAX OF 8.5, AND THE PT STILL FELT NO STIMULATION. THERE WAS NO KNOWN INCIDENT OR ACCIDENT RELATED TO THE EVENT. PER THE RPTR, THE STIMULATOR SEEMED LIKE IT MOVED IN THE POCKET, AND THE STIMULATOR COULD BE FELT THROUGH THE SKIN. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO 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 35 YR LEAD: MODEL 3889, LOT # V244043| PROGRAMMER: MODEL 3037, LOT # NJD085574N| IMPLANTED:| EXPLANTED: