BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 2609525 · Received June 11, 2012

    Report

    Report Number
    6000144-2012-03351
    Event Type
    Injury
    Date Received
    June 11, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY FOR: (B)(4) - THE DEVICE WAS RETURNED, ANALYZED AND ANALYSIS OF THE DEVICE FOUND A HIGH CURRENT DRAIN CONDITION. ELECTRICAL ANALYSIS REVEALED THE CAUSE OF THE HIGH CURRENT DRAIN WAS CURRENT LEAKAGE IN THE BATTERY FILTER CAPACITORS. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. IT WAS NOTED THAT THE DEVICE PROJECTED TO LAST 69% OF ITS EXPECTED LONGEVITY.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED AFTER BEING EXPLANTED DUE TO NORMAL BATTERY DEPLETION. THE DEVICE SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. 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 86 YR Hospitalization| R 7121 COMPETITOR IMPLANTABLE TACHY LEAD| 1058T COMPETITOR IMPLANTABLE PACING LEAD