BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO II CRT-D

    MDR report key: 1990080 · Received February 15, 2011

    Report

    Report Number
    6000144-2011-00626
    Event Type
    Injury
    Date Received
    February 15, 2011
    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
    KS, 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, PROXIMAL SEGMENT WAS RETURNED. ANALYSIS ALSO DETERMINED THAT THE DISTAL CONDUCTOR WAS STRETCHED, THERE WAS AN OUTER INSULATION COSMETIC ESC, THE OUTER INSULATION WAS TORN, THERE WAS A COSMETIC DEPRESSION ON THE OUTER INSULATION AND THERE WAS APPARENT EXPLANT DAMAGE. (B)(4): 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE LASTED TWO YEARS. IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR LEAD HAD CHRONIC HIGH THRESHOLDS. THE DEVICE WAS REMOVED AND REPLACED. THE LEFT VENTRICULAR LEAD WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    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 84 YR Hospitalization| R 6949 IMPLANTABLE TACHY LEAD| 4076 IMPLANTABLE PACING LEAD