BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO II CRT-D

    MDR report key: 2203207 · Received August 11, 2011

    Report

    Report Number
    6000144-2011-04316
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    June 2, 2011
    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
    CO, 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 RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT IMPLANT WHEN ATTEMPTING TO ATTACH THE LEADS TO THIS DEVICE THE PHYSICIAN COULD NOT GET THE SVC (SUPERIOR VENA CAVA) COIL INTO THE HEADER DESPITE REMOVING THE SET SCREW. THE DEVICE WAS REMOVED AND REPLACED WITH A NEW DEVICE. 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 43 YR Other 5076 IMPLANTABLE PACING LEAD| 0049 COMPETITOR IMPLANTABLE PACING LEAD| 0155 COMPETITOR IMPLANTABLE PACING LEAD