BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 1668432 · Received April 28, 2010

    Report

    Report Number
    2649622-2010-01890
    Event Type
    Death
    Date Received
    April 28, 2010
    Date of Event
    April 15, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. ANALYSIS OF THE LEAD IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. EVALUATION SUMMARY (B) (4) THE DEVICE LASTED 55% OF ITS EXPECTED LONGEVITY. THE DEVICE WAS FULLY FUNCTIONAL, WITH NO HIGH CURRENT DRAIN OR EVIDENCE OF BATTERY PROBLEMS. WITHOUT THE HISTORY OF THE PROGRAMMED SETTINGS THROUGHOUT ITS SERVICE LIFE, THERE IS NO WAY TO DETERMINE WHY THE LONGEVITY DID NOT MATCH THE PREDICTED MODEL. (B) (4) NO ANOMALIES FOUND. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE LEAD IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. EVALUATION SUMMARY (B) (4) THE DEVICE LASTED 55% OF ITS EXPECTED LONGEVITY. THE DEVICE WAS FULLY FUNCTIONAL, WITH NO HIGH CURRENT DRAIN OR EVIDENCE OF BATTERY PROBLEMS. WITHOUT THE HISTORY OF THE PROGRAMMED SETTINGS THROUGHOUT ITS SERVICE LIFE, THERE IS NO WAY TO DETERMINE WHY THE LONGEVITY DID NOT MATCH THE PREDICTED MODEL.

    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 DEVICE LASTED 55% OF ITS EXPECTED LONGEVITY, WITH BATTERY AT 63% ON THE DEPLETION CURVE, EQUALING 87% OF PROJECTED LONGEVITY. THE DEVICE WAS FULLY FUNCTIONAL, WITH NO HIGH CURRENT DRAIN OR EVIDENCE OF BATTERY PROBLEMS. WITHOUT THE HISTORY OF THE PROGRAMMED SETTINGS THROUGHOUT ITS SERVICE LIFE, THERE IS NO WAY TO DETERMINE WHY THE LONGEVITY DID NOT MATCH THE PREDICTED MODEL. (B)(4) PROXIMAL SEGMENT RETURNED AND ANALYZED. NO ANOMALIES FOUND. IT WAS NOTED THE OUTER TUBING OVERLAY WAS MELTED, THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND THERE WAS APPARENT EXPLANT DAMAGE. (B)(4) THE ACTUAL DEVICE WAS RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THE VENTRICULAR PACE IMPEDANCE MEASUREMENT WAS IN THE 300 OHM RANGE INITIALLY AND INCREASED GRADUALLY TO THE 1100 OHM RANGE FOR THE WEEK ENDING (B)(4) 2010. THE LAST TWO READINGS OF THE RECORD ENDING (B)(4) 2010, IN ORDER, WERE INFINITE AND 2304 OHMS. THE LIFETIME VENTRICULAR SENSING INTEGRITY COUNTER IS 4795 AND ALL COUNTS OCCURRED SINCE (B)(4) 2010. A HIGH VALUE OF THIS COUNT CAN INDICATE A POSSIBLE INTERMITTENCY IN THE SYSTEM.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS BEING REPLACED AFTER LESS THAN 5 YEARS IMPLANT DURATION. A "FAILED" LEAD (RECALLED LEAD THAT WAS FRACTURED AND OVERSENSING WITH SHOCKS) WAS BEING EXTRACTED WITH A LASER. WHEN THE LEAD WAS APPROXIMATELY HALF WAY EXTRACTED, PATIENT BECAME HEMODYNAMICALLY UNSTABLE AND IT WAS DETERMINED THE PATIENT HAD A PERICARDIAL TAMPONADE. AT THAT TIME, A PERICARDIOCENTESIS WAS PERFORMED, A SURGEON WAS CALLED, AND THE PATIENT WAS TAKEN TO SURGERY WHERE IT WAS REPORTED, THE PATIENT DIED. FOLLOW UP WITH MANUFACTURER'S REPRESENTATIVE REPORTED THE CAUSE OF DEATH IS UNKNOWN AND PRIOR TO LEAD EXTRACTION, THE PATIENT WAS STABLE. THE MANUFACTURER'S REPRESENTATIVE DOES NOT BELIEVE THE PATIENT'S DEATH WAS DEVICE RELATED.

    Description of Event or Problem · 1

    (B) (4)

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS BEING REPLACED AFTER LESS THAN 5 YEARS IMPLANT DURATION. A "FAILED" LEAD (RECALLED LEAD THAT WAS FRACTURED AND OVERSENSING WITH SHOCKS) WAS BEING EXTRACTED WITH A LASER. WHEN THE LEAD WAS APPROXIMATELY HALF WAY EXTRACTED, PATIENT BECAME HEMODYNAMICALLY UNSTABLE AND IT WAS DETERMINED THE PATIENT HAD A PERICARDIAL TAMPONADE. AT THAT TIME, A PERICARDIOCENTESIS WAS PERFORMED, A SURGEON WAS CALLED, AND THE PATIENT WAS TAKEN TO SURGERY WHERE IT WAS REPORTED, SHE DIED. FOLLOW UP WITH MANUFACTURER'S REPRESENTATIVE REPORTED THE CAUSE OF DEATH IS UNKNOWN AND PRIOR TO LEAD EXTRACTION, THE PATIENT WAS STABLE. THE MANUFACTURER'S REPRESENTATIVE DOES NOT BELIEVE THE PATIENT'S DEATH WAS DEVICE 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 77 YR Death| H| L| R 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 7278 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD| 7278 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 7278 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD