BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHRONY II

    MDR report key: 151651 · Received February 6, 1998

    Report

    Report Number
    2017865-1997-01157
    Event Type
    Injury
    Date Received
    February 6, 1998
    Date of Event
    June 10, 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
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INFORMATION RECEIVED WITH RETURN OF THE EXPLANTED DEVICE DOES NOT ADDRESS THE PATIENT'S CLINICAL STATUS BUT NOTES THAT THE PU LSE GENERATOR WAS PACING AT A RAPID RATE. WHEN INTERROGATED, "DASHES" WERE OBSERVED FOR THE RATE RRESPONSIVE PARAMETERS. ATTEMPTS TO PROGRAM THE RATE RESPONSIVE PARA- METERS WERE UNSUCCESSFUL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention