BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC LEAD

    MDR report key: 8228209 · Received January 8, 2019

    Report

    Report Number
    2182208-2019-00052
    Event Type
    Death
    Date Received
    January 8, 2019
    Date of Event
    December 1, 2018
    Report Date
    January 8, 2019
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF DEATH (DOD) WAS NOT PROVIDED; THEREFORE THE IDENTIFIED DOD AND DATE OF EVENT IS AN ESTIMATE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BY THE PATIENT'S SPOUSE THAT THE LEAD WAS 'BAD' AND THE PATIENT HAD A MASSIVE HEART ATTACK. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS REPLACED AND THE LEAD REMAINED IN USE. IT WAS ALSO REPORTED THAT SEVEN DAYS LATER THE PATIENT DIED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20582 MEDTRONIC LEAD PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 Death MDT-IPG