BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 2458881 · Received February 17, 2012

    Report

    Report Number
    2647346-2012-00137
    Event Type
    Malfunction
    Date Received
    February 17, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 RETURNED AND ANALYZED. (B)(4) PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAS BEEN ANALYZED. BATTERY VOLTAGE - BATTERY DEPLETION INDICATED/ERI: TIME OF RRT IN SAVE TO DISK ON (B)(6)-2009, DEVICE RRT<=2.62 VOLT. DAILY BATTERY VOLTAGE TREND DATA SHOWS BAT=2.64 TO 2.62 VOLTS MINIMUM BETWEEN (B)(6)-2009 AND (B)(6)-2009; 1 - PATIENT ALERT FOR LOW BATTERY VOLTAGE BETWEEN (B)(6)-2009 02:15:04. IMPEDANCE - HIGH RESISTANCE/IMPEDANCE: 2 - PATIENT ALERTS FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(6)-2007 02:15:04 AND (B)(6)-2007 02:15:04. PROGRAMMER S2D DATA FOR (B)(4) SHOWS LV PACING LEAD IMPEDANCE >2500 OHMS ON (B)(6)-2007 02:15:04 AND (B)(6)-2007 02:15:04. THE DEVICE WAS RETURNED AND ANALYZED. THE BATTERY DEPLETION WAS FOUND TO BE NORMAL AND MET EXPECTED LONGEVITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEAD WAS REMOVED AND REPLACED DUE TO UNACCEPTABLE AND ELEVATED THRESHOLDS. IT WAS FURTHER REPORTED THAT THE DEVICE ONLY LASTED TWO YEARS. THE DEVICE WAS EXPLANTED AND 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 CONCERTO CRT-D DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. C154DWK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R 6931 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB