BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3571206 · Received January 13, 2014

    Report

    Report Number
    3004209178-2014-00594
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Report Date
    December 23, 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
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3093-28, LOT# V151540, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD LOST BENEFIT, LESS THAN 50% THERAPY RELIEF, AND THE DOCTOR¿S OFFICE DID A BATTERY CHECK. THE DEVICE WAS AT END OF SERVICE (EOS) AND NORMAL BATTERY DEPLETION WAS NOTED. PRIOR TO EXPLANT THE DEVICE ALSO SHOWED HIGH IMPEDANCES, SO THE DOCTOR CHOSE TO ALSO REPLACE THE LEAD. THE NEW DEVICE WAS PUT BACK IN THE EXISTING POCKET AND THE NEW LEAD WAS PLACED ON THE LEFT SIDE. THE IMPEDANCES CHECKED OUT POSITIVELY. THREE DAYS LATER IT WAS REPORTED THAT THE PATIENT HAD IDEAL STIMULATION IN THE POST-ANESTHESIA CARE UNIT (PACU).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24088 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1