BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2539483 · Received April 18, 2012

    Report

    Report Number
    3004209178-2012-02455
    Event Type
    Injury
    Date Received
    April 18, 2012
    Report Date
    March 22, 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

    PRODUCT ID 3093-28 LOT# V203110 IMPLANTED: (B)(6) 2009 EXPLANTED: (B)(6) 2012; PRODUCT TYP LEAD; PRODUCT ID 3037 SERIAL#(B)(4); PRODUCT TYP PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND COULD NOT FEEL STIMULATION UNLESS THE AMPLITUDE WAS INCREASED HIGHER THAN NORMAL. THE PATIENT DID HAVE GOOD THERAPEUTIC RESPONSE FOR 1.5 TO 2 YEARS AFTER BEING IMPLANTED. IMPEDANCE MEASUREMENTS GREATER THAN 4,000 OHMS WERE MEASURED ON ALL BIPOLAR PAIRS WITH ELECTRODE 3. IT WAS UNKNOWN IF ELECTRODE 3 HAD BEEN USED IN PREVIOUS PROGRAMMING. A REVISION WAS PERFORMED AND THE LEAD WAS REPLACED. THE CAUSE OF THE EVENT WAS UNKNOWN. THE ISSUE WAS RESOLVED AND THE PATIENT WAS DOING FINE.

    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 Required Intervention