BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO II CRT-D

    MDR report key: 1990821 · Received February 15, 2011

    Report

    Report Number
    6000144-2011-00778
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    December 15, 2010
    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
    MI, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN THE EXISTING LEAD WAS HOOKED UP TO THE NEW DEVICE, THE SUPERIOR VENA CAVA (SVC) COIL MEASURED "NONE," WHILE THE RIGHT VENTRICULAR (RV) COIL WAS MEASURABLE. THE PHYSICIAN SWITCHED THE COILS BY PLACING THE SVC COIL IN THE RV PORT, AND THE RV COIL IN THE SVC PORT ON THE DEVICE, AND THE COIL IN THE SVC PORT STILL MEASURED "NONE." THE PHYSICIAN DECIDED TO SHUT OFF THE SVC COIL, AND THE DEVICE IS STILL 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 85 YR Required Intervention (B)(4) IMPLANTABLE TACHY LEAD