BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFP II

    MDR report key: 108437 · Received May 9, 1997

    Report

    Report Number
    2017865-1997-00748
    Event Type
    Injury
    Date Received
    May 9, 1997
    Date of Event
    October 29, 1996
    Manufacturer
    PACESETTER INC.
    Product Code
    DXY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 VENTRICULAR UNDERSENSING.~~~~~~~~~

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFP II Implant IMPLANTABLE PACEMAKER PULSE GENERATOR DXY PACESETTER INC. 283 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention