BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENRHYTHM DR

    MDR report key: 1698674 · Received May 26, 2010

    Report

    Report Number
    6000144-2010-02043
    Event Type
    Death
    Date Received
    May 26, 2010
    Date of Event
    May 18, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S38
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4)

    Additional Manufacturer Narrative · 1

    ASKU

    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 THE PATIENT WAS FOUND DEAD BY EMERGENCY MEDICAL RESPONDERS WHO REPORTED "THERE WERE NO PACING SPIKES PRESENT." THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. FOLLOW UP REVEALED A MANUFACTURER'S REPRESENTATIVE HAD INTERROGATED THE DEVICE AND IT WAS FIRING FINE. THE PATIENT HAD BEEN FOUND DEAD ON THE COUCH BY HER SON, WHO CALLED 911. NO RESUSITATION WAS PERFORMED AS THE "PATIENT HAD SIGNS OF ADVANCED DEATH." THE CAUSE OF DEATH WAS HYPERTENSIVE CARDIOVASCULAR DISEASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS FOUND DEAD BY EMERGENCY MEDICAL RESPONDERS WHO REPORTED "THERE WERE NO PACING SPIKES PRESENT." THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. FOLLOW UP REVEALED A MANUFACTURER'S REPRESENTATIVE HAD INTERROGATED THE DEVICE AND IT WAS FIRING FINE. THE PATIENT HAD BEEN FOUND DEAD ON THE COUCH BY HER SON, WHO CALLED 911. NO RESUSITATION WAS PERFORMED AS THE "PATIENT HAD SIGNS OF ADVANCED DEATH." THE CAUSE OF DEATH WAS HYPERTENSIVE CARDIOVASCULAR DISEASE. FOLLOW UP WITH CLINIC REPORTED PATIENT WAS NOT PACEMAKER DEPENDENT AND HER LAST DEVICE CHECK ON (B) (6) 2010 WAS FINE. THEY HAD CONSULTED WITH HER 1 WEEK PRIOR TO HER DEATH ABOUT MANAGING HER MEDICATIONS PRIOR TO A PROCEDURE SHE WAS GOING TO HAVE, SO HCP REMARKED THE DEATH WAS "UNEXPECTED."

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS FOUND DEAD BY EMERGENCY MEDICAL RESPONDERS WHO REPORTED "THERE WERE NO PACING SPIKES PRESENT." 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 ENRHYTHM DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. P1501DR ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death| O 5076 IMPLANTABLE PACING LEAD