BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2061145 · Received January 20, 2011

    Report

    Report Number
    3004209178-2011-00505
    Event Type
    Injury
    Date Received
    January 20, 2011
    Date of Event
    September 27, 2010
    Report Date
    January 11, 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
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS IN THE HOSPITAL FOR A PROCEDURE TO REMOVE KIDNEY STONES, AND IT WAS FOUND THAT THE PT'S IMPLANTED DEVICE WAS NOT WORKING. THE UROLOGIST NOTED THAT IT WAS "TESTED" AND "NOT WORKING". THE PT HAD BEEN AWARE THAT IT WAS NOT WORKING. IT WAS NOTED THAT "ONE OF THE WIRES WAS NO LONGER ATTACHED". A WIRE WAS FRACTURED. THE DEVICE WAS EXPLANTED. IT WAS NOTED THAT THE KIDNEY STONE REMOVAL PROCEDURE WAS NOT AN ELECTROPHYSIOLOGY PROCEDURE. ADDITIONAL INFORMATION WILL BE REPORTED IF IT IS MADE 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 24 YR Required Intervention LEAD: MODEL 3093, LOT# V162344| PROGRAMMER: MODEL 3037, LOT# NJD076615N| IMPLANTED:| EXPLANTED: