BEUDAMED
    FDA Adverse Event Death Summary report: N

    VERSA DR

    MDR report key: 1668435 · Received April 28, 2010

    Report

    Report Number
    2647346-2010-00145
    Event Type
    Death
    Date Received
    April 28, 2010
    Date of Event
    January 16, 2009
    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
    OK, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT INVOLVES A LEGAL CASE IN PROGRESS OR POTENTIAL LITIGATION. THE PROPRIETARY NATURE OF THE EVENT MAY AFFECT FOLLOW UP EFFORTS. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OUR RECORDS INDICATE THE PATIENT EXPIRED MORE THAN ONE YEAR AGO. WE HAVE NO INFORMATION FROM A HEALTH CARE PROFESSIONAL TO SUGGEST THE DEATH WAS DEVICE RELATED. IT IS NOT KNOWN IF THE DEVICE WAS EXPLANTED POST-MORTEM. THE CAUSE OF DEATH HAS BEEN RESEARCHED BUT HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    ATTORNEY ALLEGES "THAT ON (B) (6) 2009, WHILE STILL HOSPITALIZED" PATIENT "UNDERWENT SURGERY TO HAVE A PACEMAKER IMPLANTED." FURTHER ALLEGES THAT THE PACEMAKER WAS "DEFECTIVE AND CAUSED OR CONTRIBUTED TO THE DEATH" OF THE PATIENT AND "CAUSED CATASTROPHIC INJURIES TO (PATIENT) RESULTING IN HIS DEATH ON (B) (6) 2009." THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN RESEARCHED 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 71 YR Death (B) (4) IMPLANTABLE PACING LEAD| (B) (4) IMPLANTABLE PACING LEAD