BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELECTRONICS

    MDR report key: 20560 · Received March 1, 1995

    Report

    Report Number
    20560
    Event Type
    Injury
    Date Received
    March 1, 1995
    Date of Event
    August 4, 1994
    Report Date
    October 12, 1994
    Manufacturer
    TELECTRONICS
    Product Code
    DTE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    DURING ROUTINE CHECK OF PACER, NURSE NOT ABLE TO TEST ALL FACETS. MD MADE DECISION TO CHANGE PACER. UPON REMOVAL, PACER WAS ABLE TO BE PROGRAMMED. PT. DID FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELECTRONICS Implant PACEMAKER PULSE GENERATOR DTE TELECTRONICS 233F

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization