BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO II CRT-D

    MDR report key: 1925314 · Received December 14, 2010

    Report

    Report Number
    6000144-2010-06287
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    September 27, 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
    KY, 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 THE RIGHT VENTRICULAR LEAD HIGH VOLTAGE COIL EXPERIENCED HIGH IMPEDANCES, WHICH TRIGGERED A PATIENT ALERT IN TWO OCCASIONS. UPON REOPENING THE PATIENT'S DEVICE POCKET AND TESTING THE LEAD CONNECTION, IT WAS NOTED THAT THE LEAD WAS NOT PROPERLY CONNECTED TO THE DEVICE. THE CONNECTION WAS FIXED, AND BOTH THE LEAD AND DEVICE REMAIN 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 65 YR Hospitalization| O| R 4076 IMPLANTABLE PACING LEAD| 4194 IMPLANTABLE PACING LEAD