BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTRUST VR

    MDR report key: 1925757 · Received December 14, 2010

    Report

    Report Number
    6000144-2010-06343
    Event Type
    Injury
    Date Received
    December 14, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S46
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 LEAD IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(4): NO ANOMALIES FOUND. (B)(4): THE FULL LEAD IN SEGMENTS WAS RETURNED AND ANALYZED. ANALYSIS RESULTS REVEALED THAT NO ANOMALIES WERE FOUND. BLOOD/BODY FLUID WAS PRESENT ON ALL CONDUCTORS (NOT OBSTRUCTED), IN THE DEFIBRILLATION CONDUCTOR (NOT OBSTRUCTED), AND IN/ON THE HELIX MECHANISM. IT WAS NOT POSSIBLE TO DETERMINE HOW THE BLOOD HAD ENTERED THE SUPERIOR VENA CAVA LEG OF THE LEAD. IT WAS NOTED THAT THE DEFIB CONDUCTOR WAS DISTORTED, THE OUTER INSULATION WAS BREACHED CUT, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, AND THERE WAS APPARENT EXPLANT DAMAGE.

    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): NO ANOMALIES FOUND. ANALYSIS OF THE LEAD IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD AND DEVICE WERE REMOVED DUE TO INFECTION AND ENDOCARDITIS. THE DEVICE AND LEAD WERE NOT REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTRUST VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D154VRC ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R