BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GENERATOR, PERMANENT, IMPLANTABLE

    MDR report key: 3606700 · Received February 4, 2014

    Report

    Report Number
    2182208-2014-00030
    Event Type
    Death
    Date Received
    February 4, 2014
    Date of Event
    January 10, 2014
    Report Date
    January 10, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT AND DEVICE INFORMATION IS NOT KNOWN. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTION: THE FOLLOWING INFORMATION WAS INADVERTENTLY LEFT OFF OF THE INITIAL MEDWATCH REPORT: THE DATE OF THE EVENT IS UNKNOWN. THE DATE OF EVENT ENTERED IS THE DATE A MEDTRONIC EMPLOYEE BECAME AWARE OF THE EVENT AND IS THE BEST ESTIMATE. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WITH A MEDTRONIC, INC. IMPLANTABLE PULSE GENERATOR (IPG) HAD AN INFECTION AND PASSED AWAY. NO ADDITIONAL DETAILS ARE KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72077 PULSE GENERATOR, PERMANENT, IMPLANTABLE DXY MEDTRONIC, INC. MDT-IPG

    Patients

    Seq Age Sex Outcome Treatment
    1 Death