BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 1193436 · Received October 7, 2008

    Report

    Report Number
    3004209178-2008-06369
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 10, 2008
    Report Date
    September 10, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED A SHOCKING SENSATION WHEN SHE SAT DOWN. THE PATIENT TURNED THE DEVICE OFF. SHE STATED THAT THE DEVICE HAD BEEN REPROGRAMMED 4 DAYS PRIOR TO THE INCIDENT. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THE EVENT. IMPEDANCES WERE CHECKED. THEY GOT QUESTION MARKS IN THE RESULTS. IT WAS RECOMMENDED THAT THE DEFAULT TEST VALUES BE INCREASED AND THE TEST BE RE-RUN. THE PATIENT WAS ONLY PROGRAMMED TO .7 VOLTS AND TESTING AT 1.5 VOLTS WAS PAINFUL; THEY WERE NOT WILLING TO INCREASE BEYOND THAT POINT. THE PATIENT WAS SCHEDULED FOR SURGERY TO REVISE THE SYSTEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL 3 LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 7425 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention EXPLANTED:| EXTENSION: MODEL 7498| LEAD: MODEL 3998| PROGRAMMER: MODEL 7434A| EXPLANTED: