BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2053378 · Received April 13, 2011

    Report

    Report Number
    2649622-2011-05886
    Event Type
    Injury
    Date Received
    April 13, 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 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. THE SPRINT FIDELIS LEAD MODEL IS INCLUDED IN A FIELD ADVISORY. ANALYSIS OF THE LEAD IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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. EVALUATION SUMMARY: (B)(4) THE DISTAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED, AND THE DISTAL CONDUCTOR WAS FRACTURED. IT WAS ALSO NOTED THAT THE DEFIBRILLATOR CONDUCTOR WAS DISTORTED AND HAD BLOOD/BODY FLUID (NOT OBSTRUCTED), THE OUTER TUBING OVERLAY WAS MELTED, THE OUTER TUBING OVERLAY HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, THE TIP ELECTRODE HAD A WHITE SUBSTANCE, AND THERE WAS BLOOD IN/ON THE HELIX MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS DISPLACED PROXIMALLY. INTERROGATION REVEALED THERE WAS POOR SENSING AND NO CAPTURE FROM THE LEAD. IT WAS ALSO NOTED THAT THE LEAD HAD HIGH THRESHOLDS AND AN APPARENT LEAD FRACTURE. 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. 6949 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| O| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD