BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRONY III

    MDR report key: 151626 · Received February 6, 1998

    Report

    Report Number
    2017865-1997-01182
    Event Type
    Malfunction
    Date Received
    February 6, 1998
    Date of Event
    May 2, 1997
    Report Date
    June 20, 1997
    Manufacturer
    PACESETTER INC.
    Product Code
    DXY
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INFORMATION RECEIVED WITH RETURN OF THE EXPLANTED DEVICE NOTES THAT THE PATIENT IS "COMPLETELY PACEMAKER DEPENDENT". CORROSIO N OF THE FEED-THROUGH WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRONY III Implant IMPLANTABLE PACEMAKER PULSE GENERATOR DXY PACESETTER INC. 2028L NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR