BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELECTRONIC

    MDR report key: 126579 · Received July 3, 1997

    Report

    Report Number
    126579
    Event Type
    Injury
    Date Received
    July 3, 1997
    Date of Event
    May 21, 1997
    Report Date
    June 30, 1997
    Manufacturer
    TELECTRONICS
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    LASER EXTRACTION OF TELECTRONICS 330-891 ATRIAL J LEAD WITH KNOW FRACTURE. FRACTURE CONFIRMED UPON EXTRACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELECTRONIC Implant PACING LEAD DTB TELECTRONICS 330-801 *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R