BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIMA MP

    MDR report key: 151673 · Received February 6, 1998

    Report

    Report Number
    2017865-1997-01127
    Event Type
    Injury
    Date Received
    February 6, 1998
    Date of Event
    July 8, 1997
    Report Date
    May 26, 1997
    Manufacturer
    TELECTRONICS PACING SYSTEMS INC
    Product Code
    DXY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE FIELD NOTES THAT THE PATIENT WAS SEEN FOR ROUTINE FOLLOW-UP WITH NO COMPLAINTS. UPON EVALUATIO N OF THE ECG, THE DEVICE WAS PACING AT THE MAGNET RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIMA MP Implant IMPLANTABLE PACEMAKER PULSE GENERATOR DXY TELECTRONICS PACING SYSTEMS INC 155 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention