BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2062834 · Received March 25, 2011

    Report

    Report Number
    3004209178-2011-02111
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 22, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE LEAD COULD NOT BE TIGHTEN DOWN WHEN IN THE NEUROSTIMULATOR. A NEW NEUROSTIMULATOR WAS THEN IMPLANTED. THE PT RECOVERED WITHOUT SEQUELAE.

    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 79 YR EXPLANTED:| IMPLANTED:| LEAD: MODEL 3889, LOT# V579919| PROGRAMMER: MODEL 3037, LOT# NJD123325N