BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 941869 · Received November 9, 2007

    Report

    Report Number
    2649622-2007-02979
    Event Type
    Injury
    Date Received
    November 9, 2007
    Date of Event
    August 16, 2007
    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
    CO, 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. THE SPRINT FIDELIS LEAD MODEL IS INCLUDED IN A FIELD ADVISORY. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED. ANALYSIS OF THAT DATA REVEALED NOISE, ELEVATED SENSING INTEGRITY COUNTER INDICATING A POSSIBLE INTERMITTENCY IN THE SYSTEM, AND HIGH IMPEDANCE RANGING FROM 624 - 2168 OHMS. EVALUATION SUMMARY: PROXIMAL CONDUCTOR FRACTURED; FULL LEAD RETURNED AND ANALYZED. OTHER: IT WAS REPORTED THAT THE PACING IMPEDANCE WAS GREATER THAN 3000 OHMS. FRACTURE REPORTED. THE LEAD WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE PATIENT HAD A SYSTEMIC INFECTION, AND THE LEAD WAS EXPLANTED. ELECTRICAL TESTS PERFORMED. ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. MECHANICAL TESTS PERFORMED; VISUAL EXAMINATION: COMPONENT/SUBASSEMBLY FAILURE. LEAD CONDUCTOR, DEVICE WAS OUT OF SPECIFICATION IN A MANNER THAT RELATES TO EVENT, IMPEDANCE, HIGH, LEAD(S), FRACTURE OF.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE SPRINT FIDELIS LEAD MODEL IS INCLUDED IN A FIELD ADVISORY. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED. ANALYSIS OF THAT DATA REVEALED NOISE, ELEVATED SENSING INTEGRITY COUNTER INDICATING A POSSIBLE INTERMITTENCY IN THE SYSTEM, AND HIGH IMPEDANCE RANGING FROM 624 - 2168 OHMS. EVALUATION SUMMARY: PROXIMAL CONDUCTOR FRACTURED; FULL LEAD RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACING IMPEDANCE WAS GREATER THAN 3000 OHMS. FRACTURE REPORTED. THE LEAD WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE PATIENT HAD A SYSTEMIC INFECTION, AND THE LEAD WAS EXPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACING IMPEDANCE WAS GREATER THAN 3000 OHMS. FRACTURE REPORTED. THE LEAD WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE PATIENT HAD A SYSTEMIC INFECTION, AND THE LEAD WAS EXPLANTED. A LAWSUIT FURTHER ALLEGED THAT THE PATIENT RECEIVED MORE THAN 10 INAPPROPRIATE SHOCKS, AND THAT THE LEAD WAS "FAULTY".

    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 Other| R