BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO II CRT-D

    MDR report key: 4158760 · Received October 10, 2014

    Report

    Report Number
    3004209178-2014-18919
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    August 10, 2014
    Report Date
    August 18, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Removal / Correction Number
    Z-0110-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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. THIS DEVICE WAS INCLUDED IN A FIELD ACTION. BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT COULD NOT BE DETERMINED IF THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) AFTER THE DEVICE DELIVERED FOUR SHOCKS. THE PATIENT STATED A MEDICAL EQUIPMENT COMPANY REPRESENTATIVE CHECKED THE DEVICE IN THE ER AND STATED "THERE WAS NO REASON FOR (THE) DEVICE TO DELIVER THERAPY." THE PATIENT UNDERSTOOD FROM THE PHYSICIAN THAT THE DEVICE WILL BE REPLACED WHEN IT INDICATES ELECTIVE REPLACEMENT (ERI). FOLLOW-UP WITH THE PHYSICIAN'S OFFICE REVEALED THAT THE PERFORMANCE DATA REVIEWED DURING THE INTERROGATION AT THE ER WAS CLEARED AND IS NO LONGER AVAILABLE, HOWEVER, THE PATIENT WAS SEEN IN THE CLINIC SUBSEQUENT TO THE ER VISIT AND THE DEVICE WAS RE-INTERROGATED. NO LEAD ISSUES WERE NOTED THAT COULD HAVE CAUSED THE THERAPY DELIVERY, NOR WERE DEVICE ISSUES NOTED. THE PATIENT IS BEING MONITORED REMOTELY AND ERI HAS NOT BEEN REACHED YET. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637258 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 00063 YR Life Threatening 1156T LEAD, 5076-52 LEAD, 6947-65 LEAD