BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 1702062 · Received May 28, 2010

    Report

    Report Number
    2649622-2010-05119
    Event Type
    Death
    Date Received
    May 28, 2010
    Date of Event
    March 18, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0067-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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. THE LEAD IS PART OF THE ADVISORY FOR THIS MODEL. 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. IMPEDANCE - NO ANOMALIES FOUND. LEAD IMPEDANCE TRENDS STEADY. INTERFERENCE/NOISE. THE LIFETIME VENTRICULAR SENSING INTEGRITY COUNTER IS 377 AND ALL COUNTS OCCURRED WITHIN LAST THREE DAYS. A HIGH VALUE OF THIS COUNT CAN INDICATE A POSSIBLE INTERMITTENCY IN THE SYSTEM. LIA WAS INSTALLED AND WAS TRIGGERED. BASED ON FOLLOW-UP WITH MANUFACTURE REPRESENTATIVE, THE PATIENT HAD VENTRICULAR STORM WHICH WAS APPROPRIATELY TREATED AND WAS IN PULSELESS ELECTRICAL ACTIVITY AT THE END. THE PATIENT HAD MULTIPLE CO-MORBIDITIES. THERE IS NO ALLEGATION FROM A HEALTH CARE PROVIDER THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. IT WAS LATER REPORTED THE PATIENT WAS LAST SEEN IN THE CLINIC ON (B)(6)-2008. LAST DEVICE CHECK WAS (B)(6)-2009.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE LEAD IS PART OF THE ADVISORY FOR THIS MODEL. 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. IMPEDANCE - NO ANOMALIES FOUND. LEAD IMPEDANCE TRENDS STEADY. INTERFERENCE/NOISE. THE LIFETIME VENTRICULAR SENSING INTEGRITY COUNTER IS 377 AND ALL COUNTS OCCURRED WITHIN LAST THREE DAYS. A HIGH VALUE OF THIS COUNT CAN INDICATE A POSSIBLE INTERMITTENCY IN THE SYSTEM. LIA WAS INSTALLED AND WAS TRIGGERED. BASED ON FOLLOW-UP WITH MANUFACTURE REPRESENTATIVE, THE PATIENT HAD VENTRICULAR STORM WHICH WAS APPROPRIATELY TREATED AND WAS IN PULSELESS ELECTRICAL ACTIVITY AT THE END. THE PATIENT HAD MULTIPLE CO-MORBIDITIES. THERE IS NO ALLEGATION FROM A HEALTH CARE PROVIDER THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CAME TO HOSPITAL NON-RESPONSIVE. THE PATIENT WAS KNOWN TO HAVE INCREASING USE OF THE DEVICE TO TREAT APPROPRIATELY DETECTED ARRHYTHMIAS LIKELY RELATED TO WORSENING ISCHEMIC CARDIOMYOPATHY. REVIEW OF SAVE TO DISK BY TECHNICAL SERVICES REVEALED THE FIRST VENTRICULAR SENSING INTEGRITY COUNT OCCURRED ON (B) (6) -2010 DUE TO A COMBINATION OF SHORT INTERVAL COUNT AND NON-SUSTAINED TACHYCARDIA. THE LEAD INTEGRITY ALERT DIDN'T TRIGGER UNTIL (B) (6) 2010. VENTRICULAR FIBRILLATION EPISODES ON SAVE TO DISK SHOWED CHAOTIC RIGHT VENTRICULAR RHYTHM WITH NO ORGANIZED ATRIAL OR VENTRICULAR RHYTHMS. THE AMPLITUDE AND MORPHOLOGY OF THE RIGHT VENTRICULAR RHYTHM VARIED WITH NO PARTICULAR PATTERN REMINISCENT OF AN AGONAL RHYTHM. LATER REVIEW OF MANUFACTURING DATABASE REVEALED THE PATIENT DIED ON (B) (6) 2010.

    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 46 YR Death 4194 IMPLANTABLE PACING LEAD| (B) (4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD