BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO II CRT-D

    MDR report key: 2203840 · Received August 11, 2011

    Report

    Report Number
    6000144-2011-04441
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    May 20, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S125
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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: (B)(4) THE DEVICE WAS RETURNED AND ANALYSIS REVEALED NO ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEFT VENTRICULAR LEAD HAD NO CAPTURE. DURING THE LEAD REVISION, HALF OF THE GROMMET CAME OUT WHEN LOOSENING THE SET SCREW. IT WAS ALSO NOTED BY THE PATIENT THE DEVICE WOULD NOT PROGRAM RIGHT. THE DEVICE AND LEAD WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCERTO II CRT-D IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. D274TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| 6935 IMPLANTABLE TACHY LEAD