BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIRTUOSO DR

    MDR report key: 1871449 · Received October 15, 2010

    Report

    Report Number
    2647346-2010-00679
    Event Type
    Death
    Date Received
    October 15, 2010
    Date of Event
    May 31, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S062
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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. LATER REPORTED HOSPITAL DISCHARGE NOTES FROM THE DATE OF DISCHARGE NOTE "PATIENT DID HAVE HIS ICD INTERROGATED AND THAT WAS NORMAL, FOUND TO BE NORMAL." PATIENT'S SPOUSE REPORTED PATIENT DIED AND QUESTIONED WHY DEVICE NEVER SHOCKED PATIENT. PATIENT HAD HAD BURNING IN THE CHEST ON PREVIOUS OCCASIONS, BUT THE DEVICE WAS CHECKED REGULARLY AND NOTED TO BE "FINE." WIFE LATER REPORTED PATIENT "DIDN'T FEEL QUITE RIGHT LEADING TO THE DEVICE GOING OFF."

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. LATER REPORTED HOSPITAL DISCHARGE NOTES FROM THE DATE OF DISCHARGE NOTE "PATIENT DID HAVE HIS ICD INTERROGATED AND THAT WAS NORMAL, FOUND TO BE NORMAL." PATIENT'S SPOUSE REPORTED PATIENT DIED AND QUESTIONED WHY DEVICE NEVER SHOCKED PATIENT. PATIENT HAD BURNING IN THE CHEST ON PREVIOUS OCCASIONS, BUT THE DEVICE WAS CHECKED REGULARLY AND NOTED TO BE "FINE."

    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 SPOUSE THAT THE HOSPITAL RECORD STATED "DEVICE MALFUNCTIONED, BACKFIRED." THE PATIENT IS REPORTED TO HAVE DIED WITH QUESTIONABLE CAUSE OF DEATH REPORTED ISCHEMIC HEART DISEASE. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY PATIENT'S SPOUSE THAT THE HOSPITAL RECORD STATED "DEVICE MALFUNCTIONED, BACKFIRED." THE PATIENT IS REPORTED TO HAVE DIED WITH CAUSE OF DEATH REPORTED AS QUESTIONABLE ISCHEMIC HEART DISEASE. FOLLOW UP LATER REVEALED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2010 AFTER A SYNCOPAL EPISODE. WHILE HOSPITALIZED, THE PATIENT HAD AN ELECTROCARDIOGRAM THAT SHOWED NO CHANGE IN QT INTERVAL, A CAT SCAN OF THE BRAIN WHICH WAS UNREMARKABLE, AN ECHOCARDIOGRAM WHICH SHOWED AN EJECTION FRACTION OF 10% AND MODERATE MITRAL VALVE REGURGITATION, AND A CAROTID DUPLEX ULTRASOUND WHICH SHOWED RIGHT SIDED 50-60% STENOSIS. THE PATIENT WAS DISCHARGED ON (B)(6) 2010 AND DIED ON (B)(6) 2010. THE DEVICE WAS REPORTED TO HAVE BEEN DESTROYED IN THE FUNERAL HOME PRIOR TO CREMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY PATIENT'S SPOUSE THAT THE HOSPITAL RECORD STATED "DEVICE MALFUNCTIONED, BACKFIRED." THE PATIENT IS REPORTED TO HAVE DIED WITH CAUSE OF DEATH REPORTED AS ISCHEMIC HEART DISEASE. FOLLOW UP LATER REVEALED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2010 AFTER A SYNCOPAL EPISODE AND OTHER CONTRIBUTING FACTORS CAD AND HYPERTENSION. WHILE HOSPITALIZED, THE PATIENT HAD AN ELECTROCARDIOGRAM THAT SHOWED NO CHANGE IN QT INTERVAL, A CAT SCAN OF THE BRAIN WHICH WAS UNREMARKABLE, AN ECHOCARDIOGRAM WHICH SHOWED AN EJECTION FRACTION OF 10% AND MODERATE MITRAL VALVE REGURGITATION, AND A CAROTID DUPLEX ULTRASOUND WHICH SHOWED RIGHT SIDED 50-60% STENOSIS. THE PATIENT WAS DISCHARGED ON (B)(6) 2010 AND DIED ON (B)(6) 2010. THE DEVICE WAS REPORTED TO HAVE BEEN DESTROYED IN THE FUNERAL HOME PRIOR TO CREMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIRTUOSO DR ASKU LWS MEDTRONIC MED REL, INC. D154AWG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death| H| L| R 5076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD| 6947 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD