BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 2012460 · Received March 9, 2011

    Report

    Report Number
    2649622-2011-03167
    Event Type
    Death
    Date Received
    March 9, 2011
    Date of Event
    December 27, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0070-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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 DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES FOUND. (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND THAT VISUAL ANALYSIS WAS PERFORMED ONLY. (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND THAT VISUAL ANALYSIS WAS PERFORMED ONLY. (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE OUTER INSULATION HAD A COSMETIC DEPRESSION. ANALYST VISUAL COMMENT INCLUDE: THERE ARE FOUR SETS OF SETSCREW MARKS ON THE IS-1 PIN. ONE SET OF SETSCREW MARKS ON THE IS-1 PIN IS TOO PROXIMAL AND THREE SET IS IN THE CORRECT POSITION. IT CANNOT BE DETERMINED WHEN, BUT AT SOME TIME, THE LEAD WAS NOT FULLY INSERTED INTO THE DEVICE.

    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 LEADS IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. EVALUATION SUMMARY (B)(4) NO ANOMALIES FOUND.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ADDITIONAL INFORMATION RECEIVED FROM THE HOSPITAL INDICATES THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM WITH ASPIRATION PNEUMONIA AND WAS ADMITTED TO THE INTENSIVE CARE UNIT WITH RIGHT LOWER LOBE INFILTRATE AND CONGESTIVE HEART FAILURE EXACERBATION. A CHEST XRAY AND CT SCAN SHOWED A POSSIBLE HILAR MASS WITH OBSTRUCTIVE PNEUMONIA. THE PATIENT DEVELOPED RECURRENT ATRIAL FIBRILLATION/FLUTTER. THE PATIENT CONTINUED TO WORSEN AND WAS MADE DO NOT RESUSCITATE. THE PATIENT WENT INTO CARDIOPULMONARY ARREST AND EXPIRED. EVALUATION SUMMARY (B)(4) THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES FOUND. (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND THAT VISUAL ANALYSIS WAS PERFORMED ONLY. (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND THAT VISUAL ANALYSIS WAS PERFORMED ONLY. (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE OUTER INSULATION HAD A COSMETIC DEPRESSION. ANALYST VISUAL COMMENT INCLUDE: THERE ARE FOUR SETS OF SETSCREW MARKS ON THE IS-1 PIN. ONE SET OF SETSCREW MARKS ON THE IS-1 PIN IS TOO PROXIMAL AND THREE SET IS IN THE CORRECT POSITION. IT CANNOT BE DETERMINED WHEN, BUT AT SOME TIME, THE LEAD WAS NOT FULLY INSERTED INTO THE DEVICE.

    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

    THE DEVICE SYSTEM WAS RETURNED TO THE MANUFACTURER FOLLOWING THE PATIENT'S DEATH. THE CAUSE OF DEATH IS CARDIOPULMONARY ARREST, ATRIAL FIBRILLATION AND CHRONIC ARRHYTHMIA.

    Description of Event or Problem · 1

    ASKU

    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 74 YR Death| H| R