BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELECTRONICS 030176

    MDR report key: 65478 · Received January 24, 1997

    Report

    Report Number
    1316542-1997-00145
    Event Type
    Injury
    Date Received
    January 24, 1997
    Date of Event
    August 20, 1995
    Report Date
    January 24, 1997
    Manufacturer
    TELECTRONICS PACING SYSTEMS
    Product Code
    DTB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    UNIT WAS CUT & CAPPED DUE TO A REPORT OF A CONDUCTOR FRACTURE. NO FURTHER INJURY OR COMPLICATIONS ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELECTRONICS 030176 Implant CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE DTB TELECTRONICS PACING SYSTEMS 030-176 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention