BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT

    MDR report key: 1970713 · Received January 25, 2011

    Report

    Report Number
    2649622-2011-00112
    Event Type
    Death
    Date Received
    January 25, 2011
    Date of Event
    January 10, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S13
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS BROUGHT TO HOSPITAL VIA AMBULANCE DUE TO A POOR PHYSICAL CONDITION AND NAUSEA AND DIED "NOT LONG AFTER THAT." FURTHER REPORTED THERE WAS NO PACING FAILURE OR ARRHYTHMIAS AND THERE IS NO ALLEGATION FROM THE ATTENDING PHYSICIAN THAT THE DEATH WAS DEVICE RELATED. IT WAS LATER REPORTED THE CAUSE OF DEATH IS CONSIDERED TO BE EXACERBATION OF HEART FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS BROUGHT TO HOSPITAL VIA AMBULANCE DUE TO A POOR PHYSICAL CONDITION AND NAUSEA AND DIED "NOT LONG AFTER THAT." FURTHER REPORTED THERE WAS NO PACING FAILURE OR ARRHYTHMIAS AND THERE IS NO ALLEGATION FROM THE ATTENDING PHYSICIAN THAT THE DEATH WAS DEVICE RELATED. IT WAS LATER REPORTED THE CAUSE OF DEATH IS CONSIDERED TO BE EXACERBATION OF HEART FAILURE. FOLLOW UP LATER REPORTED THE LAST DEVICE CLINIC VISIT HAD BEEN A MONTH PRIOR TO DEATH. NO AUTOPSY WAS PERFORMED AND THE DEVICE SYSTEM WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS BROUGHT TO HOSPITAL VIA AMBULANCE DUE TO A POOR PHYSICAL CONDITION AND NAUSEA AND DIED "NOT LONG AFTER THAT." FURTHER REPORTED THERE WAS NO PACING FAILURE AND THERE IS NO ALLEGATION FROM THE ATTENDING PHYSICIAN 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 SPRINT IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6945 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| L| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB