BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO II CRT-D

    MDR report key: 1922113 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-05857
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    September 17, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S125
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    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 ANALYZED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, OVERSENSING DUE TO NOISE WAS ENCOUNTERED WHEN THE RIGHT VENTRICULAR (RV) LEAD WAS HOOKED TO THE DEVICE. A POSSIBLE GROMMET TEAR/ISSUE WAS SUSPECTED. THE DEVICE WAS REPLACED. WHEN A SECOND DEVICE WAS CONNECTED, NOISE WAS ALSO SEEN. THE RV LEAD WAS CAPPED AND REPLACED. THE SECOND DEVICE REMAINS IN USE. 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 II CRT-D IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. D274TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other 6949 IMPLANTABLE TACHY LEAD| 5568 IMPLANTABLE PACING LEAD