BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2123208 · Received June 14, 2011

    Report

    Report Number
    2649622-2011-07941
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    February 1, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0067-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. 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. EVALUATION SUMMARY: (B)(4) THE PARTIAL LEAD WAS RETURNED IN SEGMENTS AND ANALYZED. ANALYSIS REVEALED THAT THE DISTAL CONDUCTOR FRACTURED. THE OUTER TUBING OVERLAY HAD BLOOD/BODY FLUID ON IT, WAS MELTED, AND HAD COSMETIC ENVIRONMENTAL STRESS CRACKING. THE OUTER TUBING WAS KINKED/BUCKLED AND HAD ENVIRONMENTAL STRESS CRACKING BREACH (NON-ELECTRICAL). THE OUTER INSULATION HAD A COSMETIC DEPRESSION. THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HAD LIGATURE NEAR SLEEVE AND THERE WAS A HIGH IMPEDANCE. THE LEAD WAS REMOVED AND ANOTHER WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    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 Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB