BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2123459 · Received June 14, 2011

    Report

    Report Number
    2649622-2011-08127
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    March 7, 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. EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS ALSO NOTED THAT THE OUTER INSULATION WAS BREACHED CUT, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, THERE WAS BLOOD IN/ON THE HELIX MECHANISM, THERE WAS APPARENT EXPLANT DAMAGE AND THERE WAS WHITE SUBSTANCE ON THE LEAD. (B)(4) THE PARTIAL LEAD IN SEGMENTS WAS RETURNED, ANALYZED, AND THERE WAS INTERMITTENCY BETWEEN THE PIN AND THE CAP IN THE CONNECTOR. IT WAS ALSO NOTED THAT THE DISTAL AND DEFIBRILLATOR CONDUCTORS WERE DISTORTED, SEVERAL CONDUCTORS HAD BLOOD/BODY FLUID (NOT OBSTRUCTED), THERE WAS BLOOD/BODY FLUID IN THE OUTER TUBING OVERLAY, THE INNER INSULATION WAS KINKED/BUCKLED, THE OUTER TUBING OVERLAY WAS MELTED, THE OUTER TUBING OVERLAY HAD COSMETIC ENVIRONMENTAL STRESS CRACKING AND A NON-ELECTRICAL BREACH, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, AND THERE WAS BLOOD IN/ON THE HELIX MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROPHYLACTIC EXTRACTION OF THE RIGHT VENTRICULAR LEAD, THE ATRIAL LEAD WAS DISLODGED. BOTH LEADS WERE EXPLANTED AND REPLACED. THE RIGHT VENTRICULAR LEAD TESTED OUT OF SPECIFICATION DURING ANALYSIS. NO PATIENT COMPLICATIONS WERE 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 71 YR Hospitalization| R 7288 IMPLANTABLE PACEMAKER/CARDIO/DEFIB