BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2203177 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11834
    Event Type
    Injury
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0068-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. EVALUATION SUMMARY: (B)(4) THE PARTIAL LEAD WAS RETURNED IN SEGMENTS AND ANALYZED. PRIMARY RESULTS REVEALED THAT THE DISTAL CONDUCTOR WAS FRACTURED. THE DISTAL CONDUCTOR WAS ALSO DISTORTED. BLOOD/BODY FLUID WAS PRESENT ON THE OUTER TUBING OVERLAY. THE INNER INSULATION WAS KINCKED BUCKLED. THE OUTER TUBING OVERLAY WAS MELTED AND HAD COSMETIC ENVIRONMENTAL STRESS CRACKING (ESC). THE OUTER TUBING HAD ESC BREACH/BREACH (NON-ELECTRICAL). THE OUTER TUBING OVERLAY WAS BREACHED CUT. THE INSULATION HAD A WHITE SUBSTANCE AND COSMETIC DEPRESSION. BLOOD WAS ALSO PRESENT IN/ON THE HELIX/LOBE MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HAD HIGH THRESHOLDS. THE LEAD WAS REMOVED AND REPLACED. 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 86 YR Hospitalization| R 1688T COMPETITOR IMPLANTABLE PACING LEAD| 7278 IMPLANTABLE PACEMAKER/CARDIO/DEFIB