BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 2533449 · Received April 12, 2012

    Report

    Report Number
    6000144-2012-02555
    Event Type
    Injury
    Date Received
    April 12, 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
    ME, 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 FOR (B)(4): THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION THAT MEETS EXPECTED LONGEVITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE REACHED RECOMMENDED REPLACEMENT TIME (RRT) AND THERE WAS POSSIBLE EARLY BATTERY DEPLETION DUE TO HIGH OUTPUTS. THE RIGHT VENTRICULAR (RV) LEAD PACING OUTPUTS WERE 4.0 VOLTS AT 1.0 MILLISECOND. THE DEVICE WAS EXPLANTED AND REPLACED. THE PACE/SENSE PORTION OF THE RV LEAD WAS CAPPED AND REPLACED, AND THE HIGH VOLTAGE PORTIONS OF THE RV LEAD REMAINS IN USE. 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 77 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| 4195 IMPLANTABLE PACING LEAD