BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2973910 · Received February 22, 2013

    Report

    Report Number
    3004209178-2013-02980
    Event Type
    Injury
    Date Received
    February 22, 2013
    Report Date
    January 31, 2013
    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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3093-28 LOT# V224659, IMPLANTED: 2009 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR REVEALED THAT THE DEVICE WAS FUNCTIONALLY OKAY WITH INSIGNIFICANT ANOMALIES. THIS DEVICE IS INCLUDED IN THE MEDICAL DEVICE CORRECTION, "UNRETRIEVED DEVICE FRAGMENTS MODELS 3093 AND 3889 INTERSTIM TINED LEADS", EDUCATIONAL BRIEF/PHYSICIAN COMMUNICATION (DECEMBER 2010).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTRA-OPERATIVELY, THE IMPLANTABLE NEUROSTIMULATOR (INS) SHOWED IMPEDANCE VALUES GREATER THAN 4000 OHMS. THE LEAD WAS DISCONNECTED AND TESTED WITH A TEST CABLE BUT THE PHYSICIAN "GOT PROPER MOTOR RESPONSES". A NEW INS WAS PLACED AND THE IMPEDANCE VALUES STILL SHOWED OVER 4000 OHMS. THE LEAD WAS THEN REPLACED AND IMPEDANCE VALUES SHOWED WITHIN NORMAL RANGE. THE LEAD REPORTEDLY BROKE DURING EXPLANT AND THE ELECTRODES REMAIN IN THE PATIENT. IT WAS REPORTED, THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78291 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention