BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2800535 · Received October 22, 2012

    Report

    Report Number
    3004209178-2012-09426
    Event Type
    Injury
    Date Received
    October 22, 2012
    Report Date
    October 9, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT # VA01XE8, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. PRODUCT ID 3080, LOT # L60922, IMPLANTED: (B)(6) 1999, PRODUCT TYPE LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A NEW LEAD AN IMPLANTABLE NEUROSTIMULATOR (INS) ABOUT 2 WEEKS AGO IN THE SACRAL-4 (S4) AREA. IT WAS NOTED THAT THE PATIENT WAS NOT "GETTING AS GOOD OF A THERAPEUTIC RESPONSE" SO THE LEAD WAS MOVED TO THE S3. IT WAS FURTHER NOTED THAT THERE WAS "A BETTER STIMULATION RESPONSE FROM THE PATIENT." IT WAS CONFIRMED THAT THE PATIENT'S OLD LEAD AND NEWER LEAD WERE NOT TOUCHING BY PERFORMING A FLUOROSCOPY TEST. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD A STAGE 1 IMPLANT PERFORMED ON (B)(6) 2012. IT WAS NOTED THAT THE OLD LEAD WAS PARTIALLY REMOVED ON (B)(6) 2012 AND THE NEW LEAD WAS PLACED AND ATTACHED TO THE NEW INS. NO MALFUNCTION WAS REPORTED. IT WAS NOTED THAT THE PATIENT WAS "DOING WELL WITH HER NEW LEAD."

    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