BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO II CRT-D

    MDR report key: 1854665 · Received October 5, 2010

    Report

    Report Number
    6000144-2010-04305
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    August 16, 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
    FL, 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) : THE ACTUAL LONGEVITY IS < 80% OF 99.9% LONGEVITY LIMIT. THE DEVICE WAS FULLY FUNCTIONAL WITH NO HIGH CURRENT DRAIN OR EVIDENCE OF BATTERY PROBLEMS. WITHOUT THE HISTORY OF THE PROGRAMMED SETTINGS THROUGHOUT ITS SERVICE LIFE, THERE IS NO WAY TO DETERMINE WHY THE LONGEVITY DID NOT MATCH THE PREDICTED MODEL.

    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.

    Description of Event or Problem · 1

    ASKU

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEVICE WAS ABRUPTLY AT RRT (RECOMMENDED REPLACEMENT TIME) WITH NO PATIENT THERAPIES. THE OUTPUTS ON ALL THREE LEADS ARE LOW. IT WAS FURTHER REPORTED THE DEVICE WAS AT RRT FASTER THAN EXPECTED. THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    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 72 YR Hospitalization| O| R 4193 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 6932 IMPLANTABLE TACHY LEAD