BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENCOR DEC

    MDR report key: 217552 · Received March 31, 1999

    Report

    Report Number
    1723248-1999-00182
    Event Type
    Injury
    Date Received
    March 31, 1999
    Date of Event
    February 17, 1999
    Report Date
    March 31, 1999
    Manufacturer
    TELECTRONICS PACING SYSTEMS
    Product Code
    DTB
    Removal / Correction Number
    Z-1771/1772/5
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE LEAD WAS EXPLANTED DUE TO A REPORT OF J RETENTION WIRE FRACTURE WITHOUT PROTRUSIONS THROUGH THE OUTER POLYURETHANE INSULATION. PLEASE NOTE: ON THE PREVIOUS REPORT THE CORRECT EVENT DATE SHOULD BE 1/13/99. EXPLANT METHOD: INTRAVASCULAR, SUPERIOR TECHNIQUE/TOOLS: DIRECT TRACTION NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENCOR DEC Implant PERM IMPL PACER ELECTRODE DTB TELECTRONICS PACING SYSTEMS 033-856 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other