BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENCOR DEC

    MDR report key: 1861238 · Received September 30, 2010

    Report

    Report Number
    1723248-2010-00006
    Event Type
    Malfunction
    Date Received
    September 30, 2010
    Date of Event
    August 26, 2010
    Report Date
    September 28, 2010
    Manufacturer
    TELECTRONICS PACING SYSTEMS
    Product Code
    DTB
    Removal / Correction Number
    Z-1771/1772/5
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RECEIVED REPORTED FRACTURE OF J WIRE SUSPECTED BUT NOT VISUALIZED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other