BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENTRUST AT

    MDR report key: 2020908 · Received March 16, 2011

    Report

    Report Number
    6000144-2011-01063
    Event Type
    Death
    Date Received
    March 16, 2011
    Date of Event
    June 2, 2006
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S46
    Removal / Correction Number
    Z-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 6949 LEAD 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 FULL LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. IT WAS NOTED THAT ALL CONDUCTORS WERE STRETCHED, PROXIMAL CONDUCTOR BLOOD/BODY FLUID (NOT OBSTRUCTED), OUTER INSULATION BREACHED CUT, BLOOD IN/ON HELIX/LOBE MECHANISM (SLEEVE HEAD), APPARENT EXPLANT DAMAGE, AND VISUAL ANALYSIS PERFORMED ONLY. (B)(4): THE FULL LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. IT WAS NOTED THAT SEVERAL CONDUCTORS BLOOD/BODY FLUID (NOT OBSTRUCTED), BLOOD/BODY FLUID OUTER TUBING OVERLAY, OUTER INSULATION BREACHED CUT, OUTER TUBING OVERLAY BREACHED CUT, BLOOD IN/ON HELIX/LOBE MECHANISM (SLEEVE HEAD), APPARENT EXPLANT DAMAGE, AND VISUAL ANALYSIS PERFORMED.

    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 6949 LEAD 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 FULL LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. IT WAS NOTED THAT ALL CONDUCTORS WERE STRETCHED, PROXIMAL CONDUCTOR BLOOD/BODY FLUID (NOT OBSTRUCTED), OUTER INSULATION BREACHED CUT, BLOOD IN/ON HELIX/LOBE MECHANISM (SLEEVE HEAD), APPARENT EXPLANT DAMAGE, AND VISUAL ANALYSIS PERFORMED ONLY. (B)(4) THE FULL LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. IT WAS NOTED THAT SEVERAL CONDUCTORS BLOOD/BODY FLUID (NOT OBSTRUCTED), BLOOD/BODY FLUID OUTER TUBING OVERLAY, OUTER INSULATION BREACHED CUT, OUTER TUBING OVERLAY BREACHED CUT, BLOOD IN/ON HELIX/LOBE MECHANISM (SLEEVE HEAD), APPARENT EXPLANT DAMAGE, AND VISUAL ANALYSIS PERFORMED.

    Description of Event or Problem · 1

    IT WAS ALSO REPORTED THERE WAS AN INCREASE OF ALL IMPEDANCES, NOISE OBSERVED ON THE STORED ELECTROCARDIOGRAM, THERE MAY HAVE BEEN UNDERSENSING AND VARIED R-WAVES, AND HIGH SLEW RATES WERE NOTED. APPROXIMATELY THREE YEARS AFTER THE PATIENT'S DEATH, AN ALLEGATION FROM AN ATTORNEY INDICATED THE PATIENT "SUSTAINED AND WILL CONTINUE TO SUSTAIN SEVERE PHYSICAL INJURIES, AND/OR DEATH, SEVERE EMOTIONAL DISTRESS, MENTAL ANGUISH, ECONOMIC LOSSES AND OTHER DAMAGES FOR WHICH THEY ARE ENTITLED TO COMPENSATORY AND EQUITABLE DAMAGES AND DECLARATORY RELIEF IN AN AMOUNT TO BE PROVEN AT TRIAL." ADDITIONALLY, AN ALLEGATION FROM A SECOND ATTORNEY INDICATED THE PATIENT IS DECEASED AND FURTHER NOTED "DEATH ASSOCIATED WITH EXPLANT."

    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 57 YR Death