BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENTRUST AT

    MDR report key: 2020998 · Received March 16, 2011

    Report

    Report Number
    6000144-2011-01065
    Event Type
    Death
    Date Received
    March 16, 2011
    Date of Event
    August 17, 2006
    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
    ND, 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 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS RETURNED AND ANALYZED. VISUAL EXAMINATION OF THE CONNECTOR BLOCK, GROMMETS AND SETSCREWS FOUND NO ANOMALIES. EVALUATION SUMMARY (B)(4): THE PROXIMAL SEGMENT (78 CENTIMETERS IN LENGTH) OF THE LEAD WAS RETURNED AND ANALYZED. PRIMARY ANALYSIS FINDING: NO ANOMALIES FOUND. BLOOD/BODY FLUID WAS PRESENT IN/ON ALL CONDUCTORS (NOT OBSTRUCTED). ELECTRICAL TESTING TO DETERMINE CONTINUITY OF THE CONDUCTOR(S) PASSED. THERE WAS EVIDENCE OF CUT OUTER INSULATION BREACHED. APPARENT EXPLANT DAMAGE NOTED. (B)(4) NO ANOMALIES FOUND. THE PROXIMAL SEGMENT (42 CENTIMETERS IN LENGTH) OF THE LEAD WAS RETURNED AND ANALYZED. PRIMARY ANALYSIS FINDING: NO ANOMALIES FOUND. BLOOD/BODY FLUID WAS PRESENT IN/ON ALL CONDUCTORS (NOT OBSTRUCTED). ELECTRICAL TESTING TO DETERMINE CONTINUITY OF THE CONDUCTOR(S) PASSED. THERE WAS EVIDENCE OF CUT OUTER INSULATION BREACHED. APPARENT EXPLANT DAMAGE NOTED.

    Description of Event or Problem · 1

    AN ALLEGATION FROM AN ATTORNEY INDICATED THE PATIENT DIED APPROXIMATELY TWO MONTHS POST IMPLANT OF THE RIGHT VENTRICULAR LEAD. IT WAS ALSO NOTED THE PATIENT "RETURNED TO THE HOSPITAL WITH DIFFICULTY BREATHING AND CHEST PAIN. THE PATIENT DIED LATER THAT DAY AS A RESULT OF CARDIOPULMONARY ARREST." FURTHER REVIEW OF THE EVENT REVEALED THE PATIENT DIED TWO MONTHS POST IMPLANT OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND RIGHT ATRIAL LEAD AS WELL.

    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 21 YR Death