BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 1082311 · Received July 24, 2008

    Report

    Report Number
    2649622-2008-04025
    Event Type
    Death
    Date Received
    July 24, 2008
    Date of Event
    June 16, 2008
    Report Date
    July 2, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    Z-0067-007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    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. MODEL,-MFGR DEVICE AND PT CODES USED. EVALUATION SUMMARY: PROXIMAL CONDUCTOR FRACTURED; DISTAL SEGMENT RETURNED AND ANALYZED. THE CONCLUSION CODE HAS BEEN CHANGED FROM WHAT WAS PREVIOUSLY REPORTED. THE LEAD WAS RETURNED WITH A REPORT OF 'MALFUNCTION'. DURING ADDITIONAL FOLLOW-UP, IT WAS REPORTED THE LEAD HAD HIGH IMPEDANCE AND A FRACTURE. HOWEVER, DUE TO EXCESSIVE SCARRING, A NEW LEAD COULD NOT BE PLACED. WHILE WAITING FOR ANOTHER LEAD, THE PATIENT DIED. THE CAUSE OF DEATH WAS REPORTED TO BE AN ISCHEMIC EVENT WITH ELECTRO-MECHANICAL DISSOCIATION. A 3500A REPORT STATED THE PATIENT WAS SCHEDULED FOR REPLACEMENT IN THE CATH LAB, BUT SHE DIED BEFORE THE PROCEDURE BEGAN, WITHIN 90 MINUTES OF THE LEAD EXTRACTION. AN AUTOPSY WAS NOT PERFORMED. ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED ELECTRICAL TESTS PERFORMED MECHANICAL TESTS PERFORMED VISUAL EXAMINATION COMPONENT/SUBASSEMBLY FAILURE (SELECT SPECIFIC CODE FROM CATEGORY D) LEAD CONDUCTOR DEVICE WAS OUT OF SPECIFICATION IN A MANNER THAT RELATES TO EVENT IMPEDANCE, HIGH LEAD(S), FRACTURE OF.

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED WITH A REPORT OF 'MALFUNCTION'. DURING ADDITIONAL FOLLOW-UP, IT WAS REPORTED THE LEAD HAD HIGH IMPEDANCE AND A FRACTURE. HOWEVER, DUE TO EXCESSIVE SCARRING, A NEW LEAD COULD NOT BE PLACED. WHILE WAITING FOR ANOTHER LEAD, THE PATIENT DIED. THE CAUSE OF DEATH WAS REPORTED TO BE AN ISCHEMIC EVENT WITH ELECTRO-MECHANICAL DISSOCIATION. A 3500A REPORT STATED THE PATIENT WAS SCHEDULED FOR REPLACEMENT IN THE CATH LAB, BUT SHE DIED BEFORE THE PROCEDURE BEGAN, WITHIN 90 MINUTES OF THE LEAD EXTRACTION. AN AUTOPSY WAS NOT PERFORMED.

    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 78 YR Death