BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 1920946 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-05671
    Event Type
    Injury
    Date Received
    December 13, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S031
    Removal / Correction Number
    Z-0126-2010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    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: (B)(4): 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.

    Additional Manufacturer Narrative · 1

    ASKU

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. FOLLOW-UP WITH THE PHYSICIAN'S OFFICE DETERMINED THAT THE DEVICE WAS REPLACED DUE TO END OF DEVICE LIFE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS LATER REPORTED THAT THE DEVICE WAS EXPLANTED AND REPLACED DUE TO PREMATURE BATTERY DEPLETION.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. FOLLOW-UP WITH THE PHYSICIAN'S OFFICE DETERMINED THAT THE DEVICE WAS REPLACED DUE TO END OF DEVICE LIFE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. FOLLOW-UP WITH THE PHYSICIAN'S OFFICE DETERMINED THAT THE DEVICE WAS REPLACED DUE TO END OF DEVICE LIFE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS LATER REPORTED THAT THE DEVICE WAS EXPLANTED AND REPLACED DUE TO PREMATURE BATTERY DEPLETION.

    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 61 YR Hospitalization| R 4194 IMPLANTABLE PACING LEAD| 4194 IMPLANTABLE PACING LEAD| 4194 IMPLANTABLE PACING LEAD| 4076 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| 6949 IMPLANTABLE TACHY LEAD| 4076 IMPLANTABLE PACING LEAD| 4076 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD