BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3040289 · Received April 8, 2013

    Report

    Report Number
    3004209178-2013-04841
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 18, 2013
    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

    PRODUCT ID 3093-28 LOT# V988002, PRODUCT TYPE LEAD PRODUCT ID 3058 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 3037 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3093-28 LOT# V082173, IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 3093-28 LOT# V082173, IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A NORMAL BATTERY REPLACEMENT IMPEDANCES READ GREATER THAN 4,000 OHMS. THE REPRESENTATIVE INCREASED SETTINGS AND IMPEDANCES WERE STILL GREATER THAN 4,000 OHMS. THE LEAD WAS REINSERTED SEVERAL TIMES AND THEY HAD HEARD THE SETSCREW CLICK WHEN TORQUED DOWN. IT WAS ALSO NOTED NOTHING ABNORMAL OCCURRED DURING THE PROCEDURE. IT WAS NOTED, THE LEAD WAS OLDER SO IT DID NOT HAVE BLUE MARKINGS BUT IT APPEARED TO BE FULLY INSERTED. THE LEAD DID NOT FEEL LIKE IT MOVED ONCE THE SETSCREW WAS TIGHTENED. THE PATIENT DID NOT HAVE ANY FALLS. THE SAME DAY IT WAS REPORTED THE LEADS WERE REPLACED AND THE IMPEDANCES WERE ALL WITHIN NORMAL RANGE. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143758 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00040 YR