BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO II CRT-D

    MDR report key: 3051812 · Received April 10, 2013

    Report

    Report Number
    3004209178-2013-05973
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    January 7, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED ANALYSIS OF THE RETURNED DEVICE WAS INCONCLUSIVE.

    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: PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND SUBSEQUENTLY ANALYZED. ANALYSIS FOUND NO ANOMALIES. CONCOMITANT PRODUCTS: 5076 IMPLANTABLE PACING LEAD 2011 (B)(6); 4194 IMPLANTABLE PACING LEAD 2011 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE COULD NOT BE INTERROGATED AND NO MAGNET TONES OR PACING WERE COMING FROM THE DEVICE. IT WAS ALSO REPORTED THAT THE DEVICE MAY HAVE REACHED THE ELECTIVE REPLACEMENT INDICATOR PREMATURELY. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149348 CONCERTO II CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO D274TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Hospitalization| R 6947 IMPLANTABLE DEFIB LEAD