BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELECTRONICS

    MDR report key: 126588 · Received July 3, 1997

    Report

    Report Number
    126588
    Event Type
    Injury
    Date Received
    July 3, 1997
    Date of Event
    June 2, 1997
    Report Date
    June 30, 1997
    Manufacturer
    TELECTRONICS
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    CONNECTOR/HEADER PROBLEM....OVERSENSING. LEAD OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELECTRONICS Implant PULSE GENERATOR DXY TELECTRONICS 255 *

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R