BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO II CRT-D

    MDR report key: 2131884 · Received June 16, 2011

    Report

    Report Number
    6000144-2011-03541
    Event Type
    Injury
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S125
    Removal / Correction Number
    Z-0110-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    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.

    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 BY THE PATIENT THAT HE HAS "LESS ENERGY" AND IS "SHORT OF BREATH" SINCE HE RECEIVED HIS NEW DEVICE. THE PATIENT WAS HOSPITALIZED FOR DIAGNOSTIC TESTING AND HAD HIS DEVICE REPROGRAMMED. PT IS FEELING BETTER. THE PATIENT ALSO REPORTED THAT THEY HAVE A "VERY SERIOUS CASE" OF ATRIAL FIBRILLATION. THEY FEEL "SLUGGISH, LIGHT HEADEDNESS AND FEELS LIKE A VEGETABLE." THEY FEEL AS THOUGH THEIR HEART RATE IS CONSTANTLY DROPPING TO A LOW RATE. PATIENT FEELS THAT THE PACEMAKER HAS "NEVER WORKED PROPERLY" AND THE PATIENT IS "VERY DISSATISFIED." PATIENT HAS DISCUSSED THIS WITH THE PHYSICIAN, BUT IS LOOKING FOR A SECOND OPINION. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT HE HAS "LESS ENERGY" AND IS "SHORT OF BREATH" SINCE HE RECEIVED HIS NEW DEVICE. THE PATIENT WAS HOSPITALIZED FOR DIAGNOSTIC TESTING AND HAD HIS DEVICE REPROGRAMMED. PT IS FEELING BETTER. 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 76 YR Hospitalization| L| R 5076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD| 4196 IMPLANTABLE PACING LEAD| 4196 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD