BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3562217 · Received January 8, 2014

    Report

    Report Number
    3004209178-2014-00357
    Event Type
    Injury
    Date Received
    January 8, 2014
    Report Date
    December 17, 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
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# V022883, IMPLANTED: 2007 (B)(6), EXPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD HER LEAD AND NEUROSTIMULATOR REPLACED BECAUSE THE LEAD HAD MIGRATED TOWARD HER BLADDER. THE PATIENT NOTED THAT THE SYSTEM WORKED PRIOR TO THE ISSUE. THE PATIENT STATED THAT THE NEW LEAD PLACEMENT SHOULD WORK BETTER ACCORDING TO HER DOCTOR AND THE NEW SYSTEM WAS STILL BEING PROGRAMMED. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14097 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention