BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 2052296 · Received April 12, 2011

    Report

    Report Number
    2649622-2011-07132
    Event Type
    Death
    Date Received
    April 12, 2011
    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
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORTED EVENT WAS RECEIVED ON (B)(6) 2011. OF NOTE, THE REPORTABLE MALFUNCTION AND/OR SERIOUS INJURY OF LEAD FRACTURE, OVERSENSING, NO CAPTURE AND HIGH IMPEDANCE IS NORMALLY SUBMITTED VIA A REMEDIAL ACTION EXEMPTION REPORT THAT WOULD HAVE BEEN SUBMITTED (B)(6) 2011. INFORMATION WAS SUBSEQUENTLY RECEIVED ON (B)(6) 2011 AND REVEALED THE PATIENT DIED. AS THERE IS NEW INFORMATION THAT REASONABLY SUGGESTS THE DEVICE HAS OR MAY HAVE CAUSED OR CONTRIBUTED TO A PATIENT DEATH, THIS EVENT NO LONGER QUALIFIES FOR REMEDIAL ACTION EXEMPTION REPORTING AND IS THEREFORE BEING SUBMITTED AS A 30-DAY REPORT. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS EVENT IS ONE OF TWO REPORTS ASSOCIATED WITH THE DEATH OF THIS PATIENT. REFERENCE REPORT NUMBERS: 2649622000-2011-07148, 2647346000-2011-00543, 2649622000-2011-07149. EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND THE PROXIMAL CONDUCTOR WAS FRACTURED. IT WAS NOTED THAT THE DISTAL AND DEFIBRILLATION COIL CONDUCTOR WERE DISTORTED, THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED), THERE WAS A FRACTURE OF THE DEFIBRILLATION CONDUCTOR, OUTER TUBING WAS KINKED/BUCKLED, OUTER INSULATION WAS MELTED, OUTER TUBING OVERLAY WAS MELTED AND HAD ENVIRONMENTAL STRESS CRACKING, OUTER TUBING OVERLAY HAD AN ENVIRONMENTAL STRESS CRACKING BREACH/BREACH (NON-ELECTRICAL), OUTER INSULATION WAS BREACHED CUT, THERE WAS A WHITE SUBSTANCE ON THE EXPOSED DEFIBRILLATION COIL/ OUTER OVERLAY TUBING/TIP ELECTRODE, THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND THE LEAD WAS STRETCHED.

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORTED EVENT WAS RECEIVED ON (B)(4) 2011. OF NOTE, THE REPORTABLE MALFUNCTION AND/OR SERIOUS INJURY OF LEAD FRACTURE, OVERSENSING, NO CAPTURE AND HIGH IMPEDANCE IS NORMALLY SUBMITTED VIA A REMEDIAL ACTION EXEMPTION REPORT THAT WOULD HAVE BEEN SUBMITTED (B)(6) 2011. INFORMATION WAS SUBSEQUENTLY RECEIVED ON (B)(4) 2011 AND REVEALED THE PATIENT DIED. AS THERE IS NEW INFORMATION THAT REASONABLY SUGGESTS THE DEVICE HAS OR MAY HAVE CAUSED OR CONTRIBUTED TO A PATIENT DEATH, THIS EVENT NO LONGER QUALIFIES FOR REMEDIAL ACTION EXEMPTION REPORTING AND IS THEREFORE BEING SUBMITTED AS A 30-DAY REPORT. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS EVENT IS ONE OF TWO REPORTS ASSOCIATED WITH THE DEATH OF THIS PATIENT. REFERENCE REPORT NUMBERS: 2649622000-2011-07148, 2647346000-2011-00543, 2649622000-2011-07149. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORTED EVENT WAS RECEIVED ON (B)(6) 2011. OF NOTE, THE REPORTABLE MALFUNCTION AND/OR SERIOUS INJURY OF LEAD FRACTURE, OVERSENSING, NO CAPTURE AND HIGH IMPEDANCE IS NORMALLY SUBMITTED VIA A REMEDIAL ACTION EXEMPTION REPORT THAT WOULD HAVE BEEN SUBMITTED (B)(6) 2011. INFORMATION WAS SUBSEQUENTLY RECEIVED ON (B)(6) 2011 AND REVEALED THE PATIENT DIED. AS THERE IS NEW INFORMATION THAT REASONABLY SUGGESTS THE DEVICE HAS OR MAY HAVE CAUSED OR CONTRIBUTED TO A PATIENT DEATH, THIS EVENT NO LONGER QUALIFIES FOR REMEDIAL ACTION EXEMPTION REPORTING AND IS THEREFORE, BEING SUBMITTED AS A 30-DAY REPORT. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS EVENT IS ONE OF TWO REPORTS ASSOCIATED WITH THE DEATH OF THIS PATIENT. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    ASKU

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD FRACTURED AND THE LEAD INTEGRITY ALERT TRIGGERED. IT WAS FURTHER REPORTED THAT THE PATIENT'S HEART RHYTHM WAS ASYSTOLIC AND THE PATIENT WAS VERY SYMPTOMATIC. ADDITIONALLY, IT WAS REPORTED THAT THE LEAD WAS OVERSENSING, HAD NO CAPTURE AND HAD HIGH IMPEDANCE. THE LEAD WAS CAPPED AND REPLACED. FURTHER INFORMATION RECEIVED INDICATED THE PATIENT SUBSEQUENTLY DIED ONE DAY AFTER THE LEAD WAS CAPPED DUE TO CONGESTIVE HEART FAILURE, ELECTROMECHANICAL DISASSOCIATION AND CARDIAC ARREST.

    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 67 YR Death| H| L| O| R 4076 IMPLANTABLE PACING LEAD| 4076 IMPLANTABLE PACING LEAD| A7700 MECHANICAL HEART VALVE| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| A7700 MECHANICAL HEART VALVE| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4076 IMPLANTABLE PACING LEAD| A7700 MECHANICAL HEART VALVE