BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2557210 · Received May 2, 2012

    Report

    Report Number
    3004209178-2012-02903
    Event Type
    Injury
    Date Received
    May 2, 2012
    Date of Event
    April 4, 2012
    Report Date
    April 4, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD MODEL 3889-28, LOT# V260802, IMPLANTED: 2009-(B)(6), EXPLANTED: PROGRAMMER MODEL 3037, SERIAL# (B)(4). (B)(4).

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A REVISION TODAY DUE TO THE LOCATION OF THE INS WAS UNCOMFORTABLE. THE INS WAS GOING TO BE REPLACED WITH A 3023, ADDING AN EXTENSION, AND IMPLANTED IN THE ABDOMEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention