BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4200355 · Received October 24, 2014

    Report

    Report Number
    3004209178-2014-20356
    Event Type
    Injury
    Date Received
    October 24, 2014
    Report Date
    September 29, 2014
    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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3093-28, LOT# V875335, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WASN INITIALLY REPORTED ON (B)(6) 2013 THAT THE THERAPY NEVER WORKED FOR THE PATIENT. ALL PROGRAMS HAD BEEN TRIED AND THE REPORTER WANTED THE DEVICE REPROGRAMMED. IT WAS NOTED THE PATIENT HAD SUCCESS DURING THE TRIAL. ABOUT A WEEK LATER IT WAS NOTED THE MANUFACTURER REPRESENTATIVE HAD AN APPOINTMENT WITH THE PATIENT ON 2103-10-02. THE MANUFACTURER'S REPRESENTATIVE LATER REPORTED THAT THEY DID NOT HAVE ANY UPDATES ON THIS PATIENT. IT WAS LATER REPORTED ON (B)(6) 2014 THAT THE IMPLANT WAS REPLACED BECAUSE THE THERAPY WASN'T WORKING. A REPORTER FROM THE DOCTOR'S OFFICE NOTED THAT THE PATIENT DID NOT HAVE 50% OR GREATER SYMPTOM REDUCTION. THE EVENT CAUSE WAS NOT DETERMINED; IT WAS UNKNOWN IF IT WAS DEVICE RELATED. THE PATIENT WAS REPROGRAMMED SEVERAL TIMES WITH NO RESULTS FOR IMPROVED THERAPY. THE IMPLANTABLE NEUROSTIMULATOR (INS) AND LEAD WERE REPLACED ON (B)(6) 2014. THE PATIENT RECOVERED AFTER THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679687 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention