BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAXIMO II CRT-D

    MDR report key: 1912174 · Received December 2, 2010

    Report

    Report Number
    2647346-2010-00763
    Event Type
    Death
    Date Received
    December 2, 2010
    Date of Event
    May 1, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S084
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. EVALUATION SUMMARY: (B)(4) NO ANOMALIES FOUND. (B)(4) PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES FOUND. PROXIMAL CONDUCTOR DISTORTED, ALL CONDUCTORS BLOOD/BODY FLUID (NOT OBSTRUCTED), OUTER INSULATION COSMETIC DEPRESSION, APPARENT EXPLANT DAMAGE, AND VISUAL ANALYSIS PERFORMED ONLY. (B)(4) PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES FOUND. ALL CONDUCTORS BLOOD/BODY FLUID (NOT OBSTRUCTED), OUTER INSULATION COSMETIC DEPRESSION, VISUAL ANALYSIS PERFORMED ONLY. (B)(4) PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES FOUND. ALL CONDUCTORS BLOOC/BODY FLUID (NOT OBSTRUCTED), OUTER INSULATION COSMETIC DEPRESSION, AND VISUAL ANALYSIS PERFORMED ONLY.

    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 WERE FOUND. (B)(4) PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. PROXIMAL CONDUCTOR DISTORTED, ALL CONDUCTORS BLOOD/BODY FLUID (NOT OBSTRUCTED), OUTER INSULATION COSMETIC DEPRESSION, APPARENT EXPLANT DAMAGE, AND VISUAL ANALYSIS PERFORMED ONLY. (B)(4) PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. ALL CONDUCTORS BLOOD/BODY FLUID (NOT OBSTRUCTED), OUTER INSULATION COSMETIC DEPRESSION, VISUAL ANALYSIS PERFORMED ONLY. (B)(4) PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. ALL CONDUCTORS BLOOD/BODY FLUID (NOT OBSTRUCTED), OUTER INSULATION COSMETIC DEPRESSION, AND VISUAL ANALYSIS PERFORMED ONLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED APPROXIMATELY SIX MONTHS AFTER DEVICE REPLACEMENT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED APPROXIMATELY SIX MONTHS AFTER DEVICE REPLACEMENT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. BASED ON FOLLOW UP RECEIVED FROM THE PHYSICIAN'S OFFICE, THE PATIENT FELL APPROXIMATELY THREE MONTHS PRIOR TO THE PATIENT'S DEATH AND NO COMPLICATIONS WERE REPORTED. IT WAS ALSO REPORTED THAT WHILE WAITING IN THE PHYSICIAN'S OFFICE AFTER AN OFFICE VISIT, THE PATIENT DIED OF RESPIRATORY FAILURE. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE AND/OR LEAD RELATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death| O