BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1663223 · Received April 21, 2010

    Report

    Report Number
    2649622-2010-01883
    Event Type
    Death
    Date Received
    April 21, 2010
    Date of Event
    November 30, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. 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.

    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. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. 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. ATTORNEY LATER ALLEGES THAT "ON OR ABOUT (B)(6), 2007, (PATIENT)WAS ADMITTED TO THE MEDICAL CENTER. HE STATED HE FELT A SPASM AND WHAT FELT LIKE CHEST PAIN. STATED THIS WAS THE FIRST TIME AICD WENT OFF. (PATIENTS) AICD FIRED 3 TIMES. ON (B)(6), 2007, WHILE STILL IN THE HOSPITAL, (PATIENT) CAME IN TO REVIEW THE AICD AND ADJUSTMENTS WERE MADE AT THAT TIME TO CORRECT RECURRENT SHOCK. AT NO TIME DURING HIS HOSPITAL STAY DID MEDTRONIC ADVISE (PATIENT) THAT HIS DEVICE WAS RECALLED. AS A DIRECT AND PROXIMATE RESULT OF DEFENDANT'S CONDUCT, (PATIENT) SUFFERED CONSCIOUS PAIN AND SUFFERING, PERSONAL INJURIES, HARM, AN UNTIMELY DEATH, AND OTHER COMPENSABLE INJURIES."

    Description of Event or Problem · 1

    ATTORNEY ALLEGES THE PATIENT "PASSED AWAY ON (B) (6) 2008, DUE TO CONGESTIVE HEART FAILURE. THERE WAS A RECALL BEGINNING IN 2005 DUE TO THE POSSIBILITY OF THE DEVICE EXPERIENCING RAPID BATTERY DEPLETION DUE TO A SPECIFIC INTERNAL BATTERY SHORT MECHANISM. IF THE SHORT OCCURS, WHICH WE BELIEVE MAY HAVE LEAD TO (PATIENT'S) CONGESTIVE HEART FAILURE, DEPLETION CAN TAKE PLACE WITHIN A FEW HOURS TO A FEW DAYS. (PATIENT) LIVED FOR FIVE YEARS, ENDURING PAIN AND SUFFERING DURING THAT FIVE YEAR PERIOD DUE TO THE DEFECTIVE DEVICE. HIS ONCE ACTIVE LIFESTYLE WAS ALTERED BY HIS EXPERIENCING FATIGUE AND SHORTNESS OF BREATH." 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. REVIEW OF MANUFACTURER'S DATABASE VERIFIED PATIENT DEATH AND THAT PATIENT DID NOT HAVE A RECALLED LEAD IMPLANTED.

    Description of Event or Problem · 1

    ATTORNEY ALLEGES THE PATIENT "PASSED AWAY ON (B)(6), 2008 DUE TO CONGESTIVE HEART FAILURE. THERE WAS A RECALL BEGINNING IN 2005 DUE TO THE POSSIBILITY OF THE DEVICE EXPERIENCING RAPID BATTERY DEPLETION DUE TO A SPECIFIC INTERNAL BATTERY SHORT MECHANISM. IF THE SHORT OCCURS, WHICH WE BELIEVE MAY HAVE LEAD TO (PATIENT'S) CONGESTIVE HEART FAILURE, DEPLETION CAN TAKE PLACE WITHIN A FEW HOURS TO A FEW DAYS. (PATIENT) LIVED FOR FIVE YEARS, ENDURING PAIN AND SUFFERING DURING THAT FIVE YEAR PERIOD DUE TO THE DEFECTIVE DEVICE. HIS ONCE ACTIVE LIFESTYLE WAS ALTERED BY HIS EXPERIENCING FATIGUE AND SHORTNESS OF BREATH." 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. REVIEW OF MANUFACTURER'S DATABASE VERIFIED PATIENT DEATH AND THAT PATIENT DID NOT HAVE A RECALLED LEAD IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO SECURE ASKU LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death