BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3893911 · Received June 25, 2014

    Report

    Report Number
    3004209178-2014-12013
    Event Type
    Injury
    Date Received
    June 25, 2014
    Report Date
    June 3, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3 889-28, LOT# V078038, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WASN¿T MAKING IT TO THE BATHROOM PRIOR TO THE IMPLANTABLE NEUROSTIMULATOR (INS) BEING REPLACED AND INS WAS REPLACED IN ABOUT 2 WEEKS. THE INS STARTED ACTING UP PRIOR TO THE PATIENT LOOSING BLOOD AND IT KEPT GETTING WORSE. IT WAS NOTED THAT THE PATIENT WAS GOING THROUGH MAY BE 20 OR 25 SUPER PADS A DAY AND THE PATIENT SAW THEIR HEALTH CARE PROVIDER (HCP) AND FOUND OUT THAT THE INS WAS DEAD. THE PATIENT WAS TOLD THAT THE INS WOULD LAST 3.5 TO 5 YEARS AND IT WOULD BE 3 YEARS THIS COMING SEPTEMBER. IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. THE PATIENT WAS ALSO IN THE HOSPITAL FOR ANOTHER PROBLEM PRIOR TO REPLACEMENT OF THEIR INS. IT WAS NOTED THAT THEY HAD TO GIVE THE PATIENT 6 UNITS OF BLOOD BECAUSE THEIR BLOOD COUNT WAS DOWN TO 3.8 WHEN THEY WENT TO THE EMERGENCY ROOM (ER). THE ATTRIBUTED IT TO THE PATIENT¿S RHEUMATOLOGIST HAVING THE PATIENT ON ALEVE TWICE A DAY AND THE PATIENT WAS ON BABY ASPIRIN FROM THEIR FAMILY HCP. IT WAS REPORTED THAT THE PATIENT HAD HAD EVERY TEST IMAGINABLE SHOW OK SO NOW THE PATIENT COULDN¿T TAKE ALEVE. IT WAS ALSO NOTED THAT THE PATIENT HAD 11 BACK SURGERIES.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTS THE BATTERY DEPLETION WAS NORMAL. IT WAS NOTED THAT THE PATIENT DEVICE WAS IN A CYCLING SETTING. IT WAS REPORTED THAT THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT. IT WAS NOTED THAT THE PATIENT NEED TO REPROGRAM TO TRY TO IMPROVE EFFICACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372065 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention