BEUDAMED
    FDA Adverse Event Death Summary report: N

    VERSA DR

    MDR report key: 1891576 · Received November 5, 2010

    Report

    Report Number
    2647346-2010-00716
    Event Type
    Death
    Date Received
    November 5, 2010
    Date of Event
    October 8, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 BY THE PATIENT'S DAUGHTER THAT THE DEVICE SYSTEM WAS EXPLANTED (AND REPLACED) DUE TO INFECTION. REVIEW OF MANUFACTURER'S DATABASE REVEALED THE PATIENT DIED THE NEXT DAY. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. FOLLOW UP WITH CLINIC LATER REPORTED PATIENT WAS LAST SEEN BY THE DOCTOR APPROXIMATELY TWO MONTHS PRIOR TO DEATH AND HAD LAST DEVICE CHECK A MONTH PRIOR TO THAT. SHE REPORTED THERE ARE NO DETAILS AVAILABLE AS THE PATIENT CHART WAS ARCHIVED AND NOT AVAILABLE TO THEM.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S DAUGHTER THAT THE DEVICE SYSTEM WAS EXPLANTED (AND REPLACED) DUE TO INFECTION. REVIEW OF MANUFACTURER'S DATABASE REVEALED THE PATIENT DIED THE NEXT DAY. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSA DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC MED REL, INC. VEDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death| H| L| R