BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAXIMO II CRT-D

    MDR report key: 1913387 · Received December 3, 2010

    Report

    Report Number
    2647346-2010-00771
    Event Type
    Death
    Date Received
    December 3, 2010
    Date of Event
    June 7, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S084
    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. EVALUATION SUMMARY: (B)(4) NO ANOMALIES FOUND. (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), BLOOD/BODY FLUID OUTER TUBING OVERLAY. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    Additional Manufacturer Narrative · 1

    ASKU

    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 ARE IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. EVALUATION SUMMARY: (B)(4) NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DIED ON (B)(6) 2010 APPROXIMATELY SIX MONTHS AFTER IMPLANT OF A DEVICE AND TWO LEADS. FOLLOW UP WITH THE PHYSICIAN REPORTED THE CAUSE OF DEATH WAS ENDOCARDITIS AND WAS NOT DEVICE RELATED. THE PATIENT HAD BEEN HOSPITALIZED SHORTLY BEFORE HER DEATH AND HAD A LONG HISTORY OF HEART FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DIED ON (B)(6) 2010 APPROXIMATELY SIX MONTHS AFTER IMPLANT OF A DEVICE AND TWO LEADS. FOLLOW UP WITH THE PHYSICIAN REPORTED THE CAUSE OF DEATH WAS ENDOCARDITIS AND WAS NOT DEVICE RELATED. THE PATIENT HAD BEEN HOSPITALIZED SHORTLY BEFORE HER DEATH AND HAD A LONG HISTORY OF HEART FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DIED ON (B)(6) 2010 APPROXIMATELY SIX MONTHS AFTER IMPLANT OF A DEVICE AND TWO LEADS. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMO II CRT-D ASKU NIK MEDTRONIC MED REL, INC. D284TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death