BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENCOR

    MDR report key: 34576 · Received July 8, 1996

    Report

    Report Number
    34576
    Event Type
    Injury
    Date Received
    July 8, 1996
    Date of Event
    March 15, 1996
    Report Date
    April 2, 1996
    Manufacturer
    TELECTRONICS PACING SYSTEMS, INC.
    Product Code
    DTB
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS ADMITTED FOR REMOVAL OF LEAD THAT WAS WORKING PRIOR TO CABG SURGERY ON 3/4/96. POST OPERATIVELY, THE LEAD FAILED TO EITHER SENSE OR PACE. LEAD EXTRACTION PROGRESSED UNTIL THE LEAD FRACTURED, LEAVING A 5CM PORTION INCLUDING ELECTRODES REMAINING. THIS PORTION COULD NOT BE REMOVED, HAVING BEEN SUTURED TO THE ENDOCARDIUM ON 3/4/96. THE PT WAS RETURNED TO ANOTHER HOSP WHERE THE REMAINING PORTION WAS SURGICALLY REMOVED. THEIR REPORT CONCERNING THIS INCIDENT IS 220118-1996-0001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENCOR Implant IMPLANTABLE TRANSVENOUS PACER LEAD DTB TELECTRONICS PACING SYSTEMS, INC. 330-854 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention