BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2931890 · Received January 28, 2013

    Report

    Report Number
    3004209178-2013-01059
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Report Date
    January 11, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT# VA03E5D, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND INDICATED THAT THE STIMULATION WAS TURNING OFF BY ITSELF. THE PATIENT WAS IMPLANTED A WEEK PRIOR TO THE REPORT. THERE WAS NO KNOWN INCIDENT OR ACCIDENT RELATED TO THE EVENT. THE PATIENT EXPERIENCED A RETURN OF FREQUENCY THE PREVIOUS DAY AND CHECKED HER IMPLANT AND IT WAS OFF. THE PATIENT WORKS IN A POLICE OFFICE AND STATES THAT SHE WAS NOT EXPOSED TO ANY SECURITY SYSTEMS. THE PATIENT HAD A POST-SURGICAL CHECK ON THE DAY OF THE REPORT AND WAS GOING TO TALK TO HER PHYSICIAN ABOUT THE EVENT. FURTHER INFORMATION HAS BEEN REQUESTED. IF MORE INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37886 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1