BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 1072011 · Received July 10, 2008

    Report

    Report Number
    2647346-2008-00317
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    March 6, 2008
    Report Date
    February 21, 2024
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO ANOMALIES WERE FOUND. GROMMET DAMAGE WAS NOTED DURING DEVICE ANALYSIS, BUT IS NOT CONSIDERED A DEVICE PROBLEM.

    Description of Event or Problem · 1

    ASKU

    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 NA Unknown Required Intervention| O 4076 IMPLANTABLE PACING LEAD| 4076 IMPLANTABLE PACING LEAD| 4193 IMPLANTABLE PACING LEAD| 4193 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| 6949 IMPLANTABLE TACHY LEAD| 6949 IMPLANTABLE TACHY LEAD| 4193 IMPLANTABLE PACING LEAD| 4076 IMPLANTABLE PACING LEAD