BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMA MPT III

    MDR report key: 246309 · Received January 14, 1999

    Report

    Report Number
    2017865-1999-00211
    Event Type
    Malfunction
    Date Received
    January 14, 1999
    Date of Event
    October 12, 1998
    Manufacturer
    TELECTRONICS PACING SYSTEMS INC
    Product Code
    DXY
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE FIELD NOTES THAT THE PATIENT WAS SEEN IN THE HEALTH CLINIC FOR OTHER HEALTH PROBLEMS. IT WAS NOTED THAT HIS HEART RATE WAS ERRATIC. THE DEVICE WAS OVERSENSING IN ALL PROGRAMMED SENSITIVITIES. THE DEVICE WAS EXPOSED TO THERAPEUTIC RADIATION TWO YEARS PRIOR AND HAD NOT BEEN CHECKED SINCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIMA MPT III Implant IMPLANTABLE PACEMAKER PULSE GENERATOR DXY TELECTRONICS PACING SYSTEMS INC 5281D NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR