BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXIMO II CRT-D

    MDR report key: 1920819 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-05655
    Event Type
    Malfunction
    Date Received
    December 13, 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
    IN, 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 DEVICE WAS FULLY FUNCTIONAL WITH NO HIGH CURRENT DRAIN OR EVIDENCE OF BATTERY PROBLEMS. THE DEVICE LASTED 63% OF ITS EXPECTED LONGEVITY. BOTH LOADED AND UNLOADED PACING CURRENT DRAIN LEVELS WERE NORMAL FOR THIS DEVICE OVER THE RANGE OF BATTERY VOLTAGE IT OPERATED UNDER DURING ITS SERVICE TIME. THERE IS NO EVIDENCE TO INDICATE A PROBLEM WITH THE BATTERY. WITHOUT KNOWING THE PROGRAMMING HISTORY OF THIS DEVICE THERE IS NO WAY TO DETERMINE WHY IT DID NOT MEET ITS EXPECTED LONGEVITY CALCULATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BOTH RIGHT AND LEFT VENTRICULAR LEADS HAD INCREASED OR HIGH THRESHOLDS. BOTH LEADS REMAIN IN USE. IT WAS ALSO REPORTED THAT THE DEVICE WAS REPLACED AS IT HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). THE DEVICE WAS ANALYZED BY THE MANUFACTURER AND IT TESTED OUT OF SPECIFICATION. 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 IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. D284TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD