BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELECTRONIC

    MDR report key: 15289 · Received January 14, 1994

    Report

    Report Number
    15289
    Event Type
    Injury
    Date Received
    January 14, 1994
    Date of Event
    November 19, 1993
    Report Date
    November 29, 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 11/18/93 TO HAVE HIS PACEMAKER UNIT REPLACED AND LEAD IMPEDANCE CHECKED. MODEL 8220 BEING RECALLED BY THE COMPANY BECAUSE OF CONCERNS ABOUT FAILURE. LEAD IMPEDANCE 3000 OHMS AT EXAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELECTRONIC Implant PACEMAKER GENERATOR JOQ TELECTRONICS PACING SYSTEMS SSIC REFLEX 8220

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R TOBE RETURNED TO COMPANY REP.