BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3640086 · Received February 21, 2014

    Report

    Report Number
    3004209178-2014-03428
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Report Date
    January 30, 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
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3093-33, LOT# V142285, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LOSS OF THERAPEUTIC EFFECT AND THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD CAUSED SOME DISCOMFORT FOR THE PAST THREE TO FOUR WEEKS. IT WAS NOTED THAT THE PATIENT WAS COMPLETELY INCONTINENT OVER THE PAST YEAR AND THERE HAD BEEN NO FALL OR TRAUMA. IT WAS UNKNOWN WHERE THE PATIENT PROGRAMMER WAS. IT WAS REPORTED THAT THE PATIENT HAD SEEN AN UROLOGIST AT THE BEGINNING OF 2013. A WEEK LATER, IT WAS REPORTED THAT A MANUFACTURER REPRESENTATIVE DID ADDITIONAL REPROGRAMMING AND WITHOUT ANY SUCCESS CONCLUDED AT ALL FOUR ELECTRODES WERE BROKEN. IT WAS NOTED THAT CT SCANS WERE DONE OF THE PATIENT¿S ABDOMEN AND THE DEVICE WAS TURNED OFF. IT WAS REPORTED THAT THE PATIENT HAD DECIDED NOT TO PURSUE ANY FURTHER INTERVENTIONS FOR NOW AND THE PATIENT WAS FEELING BETTER THAN THE DATE OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109853 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR