BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELECTRONICS META 11

    MDR report key: 15292 · Received January 14, 1994

    Report

    Report Number
    15292
    Event Type
    Injury
    Date Received
    January 14, 1994
    Date of Event
    December 13, 1993
    Report Date
    December 16, 1993
    Manufacturer
    TELECTRONICS PACING SYSTEMS
    Product Code
    JOQ
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT ADMITTED TO THE HOSPITAL 12/13/93 TO HAVE PACEMAKER UNIT REPLACED. MODEL 1204 BEING RECALLED BY COMPANY BECAUSE OF CONCERNS ABOUT FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELECTRONICS META 11 Implant PACEMAKER GENERATOR JOQ TELECTRONICS PACING SYSTEMS 1204 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R TO BE RETURNED TO COMPANY REP.