BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHRONY II

    MDR report key: 151641 · Received February 6, 1998

    Report

    Report Number
    2017865-1997-01160
    Event Type
    Injury
    Date Received
    February 6, 1998
    Date of Event
    June 13, 1997
    Report Date
    June 20, 1997
    Manufacturer
    PACESETTER INC.
    Product Code
    DXY
    Removal / Correction Number
    NA
    Adverse Event
    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 IN 1/97 THE PATIENT WAS TREATED FOR INFECTION WITH ANTIBI OTICS. THE PATIENT NOW EXHIBITS SIGNIFICANT SKIN EROSION, PURULENT DISCHARGE AND EXTERIORIZATION OOF THE PULSE GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRONY II Implant IMPLANTABLE PACEMAKER PULSE GENERATOR DXY PACESETTER INC. 2022L NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention