BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 1861846 · Received October 8, 2010

    Report

    Report Number
    2647346-2010-00585
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    June 16, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S031
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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) 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 BOTH LEADS HAD INCREASED THRESHOLDS (RIGHT VENTRICULAR AND LEFT VENTRICULAR). BOTH LEADS ARE STILL IN USE. NO FURTHER PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE DEVICE WAS RETURNED, ANALYZED AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCERTO CRT-D DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. C154DWK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention