BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 5021825 · Received August 21, 2015

    Report

    Report Number
    3004209178-2015-16478
    Event Type
    Malfunction
    Date Received
    August 21, 2015
    Date of Event
    July 23, 2015
    Report Date
    July 28, 2015
    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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3 889-28, LOT# V244043, IMPLANTED:(B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THAT THE PATIENT HAD A SUDDEN CHANGE IN THERAPY OR SYMPTOMS ON (B)(6) 2015. THE PATIENT HAD LEAKAGE AT 6.3V. THE PATIENT PROGRAMMER WASN'T WORKING. THE PATIENT TRIED NEW BATTERIES AND THIS SOLVED THE ISSUE. THE PATIENT INCREASED STIMULATION AND NOW FELT STIMULATION JUST FINE. THE INDICATIONS FOR USE FOR THIS PATIENT WERE URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555095 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR