BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3900541 · Received June 27, 2014

    Report

    Report Number
    3004209178-2014-12221
    Event Type
    Injury
    Date Received
    June 27, 2014
    Report Date
    June 5, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT # VA081H9, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD THEIR WHOLE SYSTEM REMOVED BUT THEY DID NOT KNOW WHEN THEY HAD IT REMOVED. IT WAS NOTED THE PATIENT¿S DEVICE WAS REMOVED BECAUSE IT WAS UNCOMFORTABLE AND WAS NOT DOING ITS JOB. IT WAS STATED IT WAS LIKE THAT SINCE IMPLANT AND THE DEVICE WAS THE MOST UNCOMFORTABLE HORRIBLE THING EVER. ADDITIONAL INFORMATION FROM THE HEALTHCARE PROVIDER STATED THERE WAS NOT A 50 PERCENT OR GREATER SYMPTOM REDUCTION AND THE CAUSE OF THE EVENT WAS NOT DETERMINED. IT WAS STATED THE PATIENT HAD FOUR PROGRAMS PLACED AND THEY TRIED ALL OF THEM AND GOT NO IMPROVEMENT. IT WAS NOTED THE PATIENT WAS REPROGRAMMED ON (B)(6) 2013 AND THEIR DEVICE WAS REMOVED ON (B)(6) 2013. REPORTEDLY, THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377115 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention