BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 1920780 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-05651
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    June 23, 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
    DC, 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. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(4) A HIGH CURRENT DRAIN CONDITION WAS FOUND DURING DEVICE ANALYSIS. ELECTRICAL ANALYSIS FOUND THE CAUSE OF THE HIGH CURRENT DRAIN TO BE CURRENT LEAKAGE IN THE BATTERY FILTER CAPACITORS.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. THE DEVICE WAS RETURNED WITHOUT INFORMATION REGARDING PRODUCT PERFORMANCE. THE MANUFACTURER'S DEVICE TRACKING SYSTEM INDICATES THAT THE DEVICE WAS REPLACED. NO FURTHER 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R 4193 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| 4076 IMPLANTABLE PACING LEAD