BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 1013394 · Received March 10, 2008

    Report

    Report Number
    2649622-2008-00937
    Event Type
    Death
    Date Received
    March 10, 2008
    Date of Event
    November 6, 2007
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    Z-0067-007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. IT IS NOT KNOWN IF THE DEVICE WAS EXPLANTED POST-MORTEM. OTHER: IT WAS REPORTED BY THE PATIENT'S DAUGHTER THAT THE PATIENT COMPLAINED OF CHEST PAINS AND WENT IN TO HAVE HER DEVICE CHECKED. THE TECHNICIAN INDICATED THAT THE DEVICE HAD DELIVERED THERAPIES THREE TIMES. THE PATIENT WAS IN THE HOSPITAL WHEN THE DEVICE DELIVERED ANOTHER THERAPY AND HER HEART STOPPED RIGHT AFTER. THE PATIENT PASSED AWAY 5 DAYS AFTER GOING IN TO HAVE HER DEVICE CHECKED. THE DAUGHTER IS QUESTIONING IF THE LEAD HAS ANYTHING TO DO WITH THE PATIENT'S DEATH. ADDITIONAL INFORMATION RECEIVED FROM THE HCP REPORTS THE PATIENT DID HAVE SOME VT, THEN SUSTAINED VT/VF REQUIRING APPROPRIATE SHOCKS. THE CAUSE OF DEATH WAS SEPTIC SHOCK RESULTING IN ASYSTOLE. THERE WAS NORMAL DEVICE/SYSTEM FUNCTION AND THE DEATH WAS NOT DEVICE OR LEAD RELATED. NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S DAUGHTER THAT THE PATIENT COMPLAINED OF CHEST PAINS AND WENT IN TO HAVE HER DEVICE CHECKED. THE TECHNICIAN INDICATED THAT THE DEVICE HAD DELIVERED THERAPIES THREE TIMES. THE PATIENT WAS IN THE HOSPITAL WHEN THE DEVICE DELIVERED ANOTHER THERAPY AND HER HEART STOPPED RIGHT AFTER. THE PATIENT PASSED AWAY 5 DAYS AFTER GOING IN TO HAVE HER DEVICE CHECKED. THE DAUGHTER IS QUESTIONING IF THE LEAD HAS ANYTHING TO DO WITH THE PATIENT'S DEATH. ADDITIONAL INFORMATION RECEIVED FROM THE HCP REPORTS THE PATIENT DID HAVE SOME VT, THEN SUSTAINED VT/VF REQUIRING APPROPRIATE SHOCKS. THE CAUSE OF DEATH WAS SEPTIC SHOCK RESULTING IN ASYSTOLE. THERE WAS NORMAL DEVICE/SYSTEM FUNCTION AND THE DEATH WAS NOT DEVICE OR LEAD RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT FIDELIS IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6949 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death| O D154VWC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR