BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 2122988 · Received June 14, 2011

    Report

    Report Number
    6000144-2011-02241
    Event Type
    Injury
    Date Received
    June 14, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    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) ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. BATTERY DEPLETION/ ELECTIVE REPLACEMENT INDICATOR WAS REACHED ON (B)(4) 2011. THE REVIEW INDICATED OVERSENSING WITH MANY SENSED EVENTS REGISTERED BETWEEN (B)(4) 2010 AND (B)(4) 2011. ONLY ONE OF THESE EVENTS IS LESS THAN 200 MS. (1 EPISODE VENTRICULAR FIBRILLATION).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT REPORTED TO AN EMERGENCY DEPARTMENT DUE TO MULTIPLE SHOCKS RECEIVED FROM SUPRAVENTRICULAR TACHYCARDIA EPISODES. THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). IT WAS FURTHER REPORTED THAT THE DEVICE FUNCTIONED AS PROGRAMMED. THE DEVICE WAS REMOVED AND REPLACED WITH A NEW DEVICE. 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 59 YR Hospitalization| L| R 5076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD| 4193 IMPLANTABLE PACING LEAD