BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENGUARD 040069

    MDR report key: 106541 · Received July 14, 1997

    Report

    Report Number
    1723248-1997-00549
    Event Type
    Injury
    Date Received
    July 14, 1997
    Date of Event
    January 14, 1997
    Report Date
    July 11, 1997
    Manufacturer
    TELECTRONICS PACING SYSTEMS
    Product Code
    DTB
    Removal / Correction Number
    Z-11715
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE LEAD WAS EXPLANTED DUE TO A REPORT OF J RETENTION WIRE FRACTURE WITHOUT PROTRUSION THROUGH THE OUTER POLYURETHANE INSULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENGUARD 040069 Implant PERM IMPL PACER ELECTRODE DTB TELECTRONICS PACING SYSTEMS 040-069 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention