BEUDAMED
    FDA Adverse Event Death Summary report: N

    INSYNC SENTRY

    MDR report key: 1932015 · Received December 17, 2010

    Report

    Report Number
    6000144-2010-06940
    Event Type
    Death
    Date Received
    December 17, 2010
    Date of Event
    November 12, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S18
    Removal / Correction Number
    Z-0070-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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. 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. ANALYSIS OF THE LEADS IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. (B)(4) NO ANOMALIES FOUND.

    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) THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4) NO ANOMALIES FOUND, PROXIMAL CONDUCTOR DISTORTED, OUTER INSULATION COSMETIC ESCAND DEPRESSION AND BREACHED CUT, APPARENT EXPLANT DAMAGE. PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND, OUTER INSULATION COSMETIC DEPRESSION. PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND, DISTAL CONDUCTOR BLOOD/BODY FLUID (NOT OBSTRUCTED), OUTER TUBING OVERLAY COSMETIC ESC AND BREACHED CUT, OUTER INSULATION COSMETIC DEPRESSION, APPARENT EXPLANT DAMAGE. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    Additional Manufacturer Narrative · 1

    ASKU

    Description of Event or Problem · 1

    ASKU

    Description of Event or Problem · 1

    IT WAS NOTED THE PATIENT DIED 4 YEARS AND 7 MONTHS AFTER DEVICE IMPLANT. THE DEVICE WAS NOTED TO BE AT ERI. FOLLOW UP REVEALED DEATH CERTIFICATE SHOWS THE CAUSE OF DEATH AS RESPIRATORY ARREST DUE TO OR AS A CONSEQUENCE OF SEPSIS, DUE TO CONGESTIVE HEART FAILURE, DUE TO LYMPHOMA. AUTOPSY WAS DONE AND MANNER OF DEATH WAS DECLARED NATURAL.

    Description of Event or Problem · 1

    IT WAS NOTED THE PATIENT DIED 7 MONTHS AFTER DEVICE IMPLANT. THE DEVICE WAS NOTED TO BE AT ERI. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS NOTED THE PATIENT DIED 4 YEARS AND 7 MONTHS AFTER DEVICE IMPLANT. THE DEVICE WAS NOTED TO BE AT ERI. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYNC SENTRY ASKU NIK MEDTRONIC MED REL, INC. 7299 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death