BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2781320 · Received October 10, 2012

    Report

    Report Number
    3004209178-2012-09081
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Report Date
    September 20, 2012
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37742, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3093-33, LOT# V523343, IMPLANTED: (B)(6) 2010. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LOSS OF THERAPEUTIC EFFECT. IT WAS REPORTED THAT THE PATIENT HAD A RETURN OF SYMPTOMS, STATING THAT "IT DOESN'T WORK", AND THIS BEGAN ABOUT TWO MONTHS AGO. IT WAS REPORTED THAT THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THE ISSUE. IT WAS ALSO REPORTED THAT THE PATIENT WAS TOLD THAT THEY MAY NEED A BATTERY REPLACEMENT TWO YEARS AFTER IMPLANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1