BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENTRUST AT

    MDR report key: 1915867 · Received December 6, 2010

    Report

    Report Number
    2647346-2010-00785
    Event Type
    Death
    Date Received
    December 6, 2010
    Date of Event
    October 13, 2008
    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
    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. (B)(4) NO ANOMALIES FOUND. (B)(4) NO ANOMALIES FOUND, ALL CONDUCTORS DISTORTED, APPARENT EXPLANT DAMAGE. PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND, OUTER INSULATION COSMETIC DEPRESSION. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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. (B)(4) NO ANOMALIES FOUND, ALL CONDUCTORS DISTORTED, APPARENT EXPLANT DAMAGE. PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND, OUTER INSULATION COSMETIC DEPRESSION. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    ASKU

    Description of Event or Problem · 1

    IT WAS NOTED THE PATIENT DIED APPROXIMATELY 10 MONTHS AFTER DEVICE IMPLANT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS NOTED THE PATIENT DIED APPROXIMATELY 10 MONTHS AFTER DEVICE IMPLANT. FOLLOW UP REVEALED THE CAUSE OF DEATH WAS CORONARY ARTERY DISEASE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death