BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 1711527 · Received June 7, 2010

    Report

    Report Number
    2649622-2010-05123
    Event Type
    Death
    Date Received
    June 7, 2010
    Date of Event
    April 16, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0067-0070-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE
    Reporter Occupation
    PHYSICIAN

    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. EVALUATION SUMMARY (B) (4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. NO ANOMALIES FOUND.

    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. 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. EVALUATION SUMMARY (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. NO ANOMALIES FOUND. ATTORNEY LATER ALLEGED "ON JULY 20, 2007, A MEDTRONIC CONCERTO ICD, MODEL # C154DWK, AND A VENTRICULAR MEDTRONIC SPRINT FIDELIS LEAD, MODEL 6949, WERE IMPLANTED IN (PATIENT). (PATIENT) SUFFERED EMOTIONAL DISTRESS AS A RESULT OF THE KNOWLEDGE OF THE DEFECTIVE NATURE OF HIS SPRINT FIDELIS LEAD, AND THE KNOWLEDGE THAT, AT ANY TIME AND WITHOUT WARNING, HE COULD BE SERIOUSLY, IF NOT FATALLY, INJURED BECAUSE OF ITS DEFECTIVE NATURE." FURTHER ALLEGES THAT AS A RESULT OF THE LEAD, PATIENT "SUSTAINED EMOTIONAL DISTRESS, MENTAL ANGUISH, ECONOMIC LOSSES AND OTHER DAMAGE." THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED ON (B)(6) 2010. THERE WERE A NUMBER OF NONSUSTAINED TACHYCARDIAS WITH FAST CYCLE LENGTHS REPORTED AND RV IMPEDANCE INCREASE TO OVER 1000 OHMS. A CARE ALERT WAS TRIGGERED. FOLLOW UP REVEALED THAT AFTER DEATH WHEN BODY BEING REMOVED, "BODY BECAME CLOSE ENOUGH TO HIS MONITOR TO ACHIEVE A TELEMETRY LINK. THE THOUGHT IS THAT THE HIGHER IMPEDANCE AND NOISE ON THE ELECTOGRAM WAS AFTER THE PATIENT EXPIRED, PERHAPS FOR SOME TIME." FOLLOW UP REVEALED THE EP PHYSICIAN CONCLUDED DEATH WAS EXPECTED AND NOT DEVICE RELATED. RATHER, PATIENT APPARENTLY FELL AND RESULT OF FALL - FATAL BLOOD LOSS. "PATIENT HAD BEEN ON COUMADIN WHICH WAS STOPPED BECAUSE THE INR WAS TOO HIGH." PHYSICIAN REPORTED PATIENT HAD "WICKED END STAGE HEART DISEASE."

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED ON (B) (6) 2010. A CARE ALERT WAS TRIGGERED THAT NOTED A NUMBER OF NONSUSTAINED TACHYCARDIAS WITH FAST CYCLE LENGTHS AND RV IMPEDANCE INCREASE TO OVER 1000 OHMS. FOLLOW UP REVEALED THAT AFTER DEATH WHEN BODY BEING REMOVED, "BODY BECAME CLOSE ENOUGH TO HIS MONITOR TO ACHIEVE A TELEMETRY LINK. THE THOUGHT IS THAT THE HIGHER IMPEDANCE AND NOISE ON THE ELECTROGRAM WAS AFTER THE PATIENT EXPIRED, PERHAPS FOR SOME TIME." FOLLOW UP REVEALED THE EP PHYSICIAN CONCLUDED DEATH WAS EXPECTED AND NOT DEVICE RELATED. RATHER, PATIENT APPARENTLY FELL AND RESULT OF FALL - FATAL BLOOD LOSS. "PATIENT HAD BEEN ON COUMADIN WHICH WAS STOPPED BECAUSE THE INR WAS TOO HIGH." PHYSICIAN REPORTED PATIENT HAD "WICKED END STAGE HEART DISEASE."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death