BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3531267 · Received December 20, 2013

    Report

    Report Number
    3004209178-2013-23860
    Event Type
    Injury
    Date Received
    December 20, 2013
    Report Date
    December 4, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-41, LOT# V062662, IMPLANTED: 2008 (B)(6), EXPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT. (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

    ANALYSIS OF THE NEUROSTIMULATOR, SERIAL #(B)(4), FOUND IT FUNCTIONALLY OKAY WITH INSIGNIFICANT ANOMALIES. ANALYSIS OF THE LEAD, LOT #V062662, FOUND A SHORT BETWEEN THE CIRCUITS OF THE LEAD BODY CONDUCTORS DUE TO OVERSTRESS OR DAMAGE. THERE WERE NO SIGNIFICANT ANOMALIES.

    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 THERE WAS A LEAD MIGRATION ISSUE AND THE LEAD WAS MIGRATING THROUGH THE PATIENT¿S SKIN. IT WAS NOTED THAT THE LEAD WAS PLACED PUDENDALLY AND WAS MIGRATING THROUGH THE PERINEUM. IT WAS REPORTED THAT PATIENT SYMPTOMS INCLUDED EROSION AND PAIN AT THE LEAD LOCATION, AND PATIENT STATUS WAS NOTED AS NO INJURY. IT WAS NOTED THAT THE LEAD WAS POKING OUT OF THE PERINEUM, THE LEAD AND IMPLANTABLE NEUROSTIMULATOR WERE SUCCESSFULLY REMOVED, AND THE PATIENT WAS FINE POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667865 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention