BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 2864938 · Received December 10, 2012

    Report

    Report Number
    3004209178-2012-11432
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    October 29, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031/S031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY (B)(4): THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION. CONCOMITANT PRODUCTS: 5071 X2 IMPLANTABLE PACING LEADS 2003 (B)(6); 6947 IMPLANTABLE TACHY LEAD 2004 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SCHEDULED DEVICE CHANGE OUT, IT WAS FOUND THAT THE DEVICE WAS VERY SUPERFICIAL AND HAD BECOME DISPLACED LATERALLY IN THE AXILLA. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR [RV] LEAD HAD AN INSULATION BREACH. THE DEVICE WAS EXPLANTED AND REPLACED; THE RV LEAD WAS REPAIRED AND 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 CRT-D DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO C154DWK

    Patients

    Seq Age Sex Outcome Treatment
    1 00087 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD