BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAXIMO II CRT-D

    MDR report key: 3484694 · Received November 22, 2013

    Report

    Report Number
    3004209178-2013-21345
    Event Type
    Death
    Date Received
    November 22, 2013
    Date of Event
    May 23, 2010
    Report Date
    December 9, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    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. THE DEVICES ASSOCIATED WITH THIS ADVERSE OUTCOME WERE RETURNED AND THE PATIENT WAS IDENTIFIED AS BEING DECEASED. AT THIS TIME, NO ADDITIONAL INFORMATION IS AVAILABLE. HOWEVER, IF ADDITIONAL INFORMATION IS SUBSEQUENTLY RECEIVED IT WOULD BE PROCESSED AND CONSIDERED ACCORDINGLY. CONCOMITANT MEDICAL PRODUCTS: IMPLANTABLE PACING LEAD: PRODUCT ID 419378, IMPLANTED: (B)(6) 2007; IMPLANTABLE DEFIBRILLATION LEAD: PRODUCT ID 6 94958, IMPLANTED: (B)(6) 2007; IMPLANTABLE PACING LEAD: PRODUCT ID 5076-52, IMPLANTED: (B)(6) 2009; PRODUCT ID 5076-45, IMPLANTED: (B)(6) 2007. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY # PRODUCT ID# D284TRK, THE DEVICE WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    CLARIFICATION ON DATES FOR THE REPORTED INFORMATION WAS OBTAINED AND NOTED THE BECOMES AWARE DATE AS NOVEMBER 13, 2013. (B)(4).

    Description of Event or Problem · 1

    AN IMPLANTABLE CARDIO-VERTER DEFIBRILLATOR (ICD) SYSTEM WAS RETURNED FROM A HISTOLOGIST WITH NO INFORMATION. INFORMATION IDENTIFIED IN THE MANUFACTURE¿S DATABASE INDICATED THE PATIENT DIED APPROXIMATELY NINE MONTHS POST IMPLANT OF THE ICD, APPROXIMATELY 3.5 YEARS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609278 MAXIMO II CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO D284TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 00088 YR Death