BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2780386 · Received October 10, 2012

    Report

    Report Number
    3004209178-2012-09068
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Report Date
    September 12, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE STIMULATOR FOUND NO ANOMALY. PRODUCT ID, 3095-10 SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3093-33 LOT# V260716, IMPLANTED: 2009 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3023 SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REPLACEMENT PROCEDURE, THE DOCTOR COULD NOT INSERT THE LEAD INTO THE HEADER BLOCK ON THE NEW IMPLANTABLE NEUROSTIMULATOR (INS). THE PROCEDURE WAS TO REPLACE AN INTERSTIM DEVICE WITH AN INTERSTIM II. THE DOCTOR REMOVED THE OLD EXTENSION AND TRIED TO INSERT EXISTING LEAD INTO THE INS HEADER BLOCK, BUT COULD NOT. THE DOCTOR DECIDED TO USE A NEW EXTENSION AND AN INTERSTIM. EVERYTHING WAS WORKING "GOOD." THERE WERE NO PROBLEMS AND THE PATIENT RECOVERED WITHOUT SEQUELA.

    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