BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 4152700 · Received October 8, 2014

    Report

    Report Number
    2182208-2014-02507
    Event Type
    Death
    Date Received
    October 8, 2014
    Report Date
    September 12, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION OR DEVICE INFORMATION WAS PROVIDED SO CONTACT INFORMATION TO COMPLETE FOLLOW-UP IS NOT REASONABLY KNOWN. THE DATE OF DEATH IS UNKNOWN; THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA SOCIAL MEDIA THAT A PATIENT DIED DUE TO A DEFECTIVE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630348 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE LWS MEDTRONIC, INC. MDT-ICD

    Patients

    Seq Age Sex Outcome Treatment
    1 Death