BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 2127824 · Received June 15, 2011

    Report

    Report Number
    6000144-2011-02996
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    April 7, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S031
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. POWER ON RESET - POWER ON RESET PARAMETERS 1 - POR FOR VDD MONITOR ON (B)(6) 2011 04:25:56. 1 - PATIENT ALERT FOR DEVICE CIRCUIT ERROR ON (B)(6) 2011 04:25:56.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM AFTER RECEIVING SEVERAL SHOCKS. UPON INTERROGATION IT WAS DETERMINED THAT THE SHOCKS WERE APPROPRIATE, BUT THAT AN ELECTRICAL RESET HAD OCCURRED IN THE DEVICE. IT WAS ALSO REPORTED THAT AFTER THE LAST SHOCK THE PATIENT FELL AND HAD AN ABRASION ON THE HEAD. THE DEVICE WAS REPROGRAMMED TO A VVI MODE AND THE DETECTIONS WERE TURNED OFF. 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
    1 CONCERTO CRT-D DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. C154DWK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L| R 6931 IMPLANTABLE TACHY LEAD| COMPETITOR IMPLANTABLE PACING LEADS 2X