BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 1013554 · Received March 10, 2008

    Report

    Report Number
    2649622-2008-00861
    Event Type
    Injury
    Date Received
    March 10, 2008
    Date of Event
    February 24, 2006
    Report Date
    June 11, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    Z-0067-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THE SPRINT FIDELIS LEAD MODEL IS INCLUDED IN A FIELD ADVISORY. EVALUATION SUMMARY: DISTAL CONDUCTOR FRACTURED; PARTIAL LEAD RETURNED IN SEGMENTS.

    Description of Event or Problem · 1

    IT HAD BEEN REPORTED THE LEAD WAS OVERSENSING. THE HCP WAS UNABLE TO PASS A WIRE THROUGH THE MID COIL AND THE DISTAL TIP OF THE PACE/SENSE PORTION. THE LEAD WAS PARTIALLY REMOVED, CAPPED, AND REPLACED DUE TO AN APPARENT FRACTURE. ADDITIONAL INFORMATION RECEIVED REPORTS THE PATIENT RECEIVED SHOCKS. THE LEAD ALSO SHOWED OVERSENSING, HIGH IMPEDANCE AND FOUR SECOND PAUSES. NO FURTHER PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT FIDELIS IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6931 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown Hospitalization| R| L 4076 IMPLANTABLE PACING LEAD| 4076 IMPLANTABLE PACING LEAD| 4076 IMPLANTABLE PACING LEAD