BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PACESETTER

    MDR report key: 227661 · Received May 27, 1999

    Report

    Report Number
    227661
    Event Type
    Injury
    Date Received
    May 27, 1999
    Date of Event
    April 22, 1999
    Report Date
    May 19, 1999
    Manufacturer
    OSCAR MEDICAL INC
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    VENTRICULAR PACING LEAD FAILED TO SPIKE. LEAD WAS REPLACED ON 4/23/1999. PT WAS IN A VENTRICULAR ARRYTHMIA. OPERATIVE DIAGNOSIS: HEART BLOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PACESETTER Implant VENTRICULAR LEAD DTB OSCAR MEDICAL INC 1388T/52 *

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening| O