BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENTRUST AT

    MDR report key: 2021038 · Received March 16, 2011

    Report

    Report Number
    2647346-2011-00289
    Event Type
    Death
    Date Received
    March 16, 2011
    Date of Event
    April 11, 2007
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S46
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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. ALL INFORMATION KNOWN WAS PROVIDED PER THE COMPLAINANT. THEREFORE, NO ATTEMPTS FOR ADDITIONAL INFORMATION WILL BE MADE. THE LEAD MODEL 6949 IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. IT WAS NOTED THERE WAS OUTER INSULATION BREACHED CUT, APPARENT EXPLANT DAMAGE, AND VISUAL ANALYSIS PERFORMED ONLY. (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. IT WAS NOTED THERE WAS OUTER INSULATION COSMETIC CUT, OUTER INSULATION BREACHED CUT, APPARENT EXPLANT DAMAGE, AND VISUAL ANALYSIS PERFORMED ONLY.

    Description of Event or Problem · 1

    AN ALLEGATION FROM AN ATTORNEY INDICATED THE PATIENT DIED APPROXIMATELY ONE MONTH POST IMPLANT OF THE RIGHT VENTRICULAR LEAD. FURTHER REVIEW REVEALED THAT THE DEFIBRILLATOR AND RIGHT ATRIAL LEAD WERE ONE MONTH POST IMPLANT AS WELL. IT WAS ALSO NOTED THE PATIENT SUFFERED EXTREME PHYSICAL INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTRUST AT IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D154ATG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death