BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAXIMO VR

    MDR report key: 2032948 · Received March 29, 2011

    Report

    Report Number
    6000144-2011-01098
    Event Type
    Death
    Date Received
    March 29, 2011
    Date of Event
    July 26, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S37
    Removal / Correction Number
    Z-0070-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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) THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. THIS DEVICE WAS PREVIOUSLY REPORTED IN A SUMMARY REPORT RELATED TO A STILL IN USE RETROSPECTIVE REVIEW. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND THAT VISUAL ANALYSIS ONLY WAS PERFORMED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THE CAUSE OF DEATH WAS RENAL FAILURE, CANCER AND SEPSIS. PATIENT HAD BEEN ON A STEP-DOWN UNIT AND WAS EXTREMELY SICK AFTER RECEIVING CHEMOTHERAPY AND BEING SEPTIC WITH OPEN WOUNDS. 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. THIS DEVICE WAS PREVIOUSLY REPORTED IN A SUMMARY REPORT RELATED TO A STILL IN USE RETROSPECTIVE REVIEW. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND THAT VISUAL ANALYSIS ONLY WAS PERFORMED.

    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. THIS DEVICE WAS PREVIOUSLY REPORTED IN A SUMMARY REPORT RELATED TO A STILL IN USE RETROSPECTIVE REVIEW. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    AN IMPLANTABLE CARDIAC DEFIBRILLATOR AND TACHY LEAD WAS RETURNED TO THE MANUFACTURER WITH NO INFORMATION FOLLOWING THE PATIENT'S DEATH. THE CAUSE OF DEATH HAS BEEN REQUESTED BUT NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMO VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. 7232CX ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death