BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 1972272 · Received January 28, 2011

    Report

    Report Number
    2649622-2011-00145
    Event Type
    Death
    Date Received
    January 28, 2011
    Date of Event
    December 23, 2010
    Report Date
    March 15, 2024
    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
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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 ONE LEAD IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. (B)(4) - NO ANOMALIES FOUND. (B)(4) - NO ANOMALIES FOUND, OUTER INSULATION COSMETIC DEPRESSION. PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4) - NO ANOMALIES FOUND, OUTER INSULATION COSMETIC DEPRESSION. 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 SUMMARY - (B)(4). NO ANOMALIES FOUND. (B)(4). NO ANOMALIES FOUND, OUTER INSULATION COSMETIC DEPRESSION. PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4). NO ANOMALIES FOUND, OUTER INSULATION COSMETIC DEPRESSION. PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4). NO ANOMALIES FOUND, OUTER INSULATION COSMETIC DEPRESSION. PROXIMAL SEGMENT RETURNED AND ANALYZED. DISCLAIMER: SUBMISSION OF INFORMATION BY MEDTRONIC UNDER THE MEDICAL DEVICE REPORTING REGULATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE (S) HAS MALFUNCTIONED OR THAT THERE IS ANY CAUSAL CONNECTION BETWEEN THE PERFORMANCE OF THE DEVICE AND ANY INJURY THAT MAY HAVE OCCURRED.

    Description of Event or Problem · 1

    IT WAS NOTED THE PATIENT DIED 3 MONTHS AFTER DEVICE IMPLANT. FOLLOW UP DETERMINED THE PATIENT DIED IN A HOSPICE FACILITY AFTER AN EXTENDED ILLNESS. ADDITIONAL FOLLOWUP REPORTED THE PATIENT DIED FROM CANCER AND THE DEATH WAS NOT RELATED TO THE DEVICE.

    Description of Event or Problem · 1

    IT WAS NOTED THE PATIENT DIED 3 MONTHS AFTER DEVICE IMPLANT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED

    Description of Event or Problem · 1

    IT WAS NOTED THE PATIENT DIED 3 MONTHS AFTER DEVICE IMPLANT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. FOLLOW UP DETERMINED THE PATIENT DIED IN A HOSPICE FACILITY AFTER AN EXTENDED ILLNESS.

    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 60 YR Male Death