BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 2050840 · Received April 12, 2011

    Report

    Report Number
    6000144-2011-01489
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    December 19, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S031
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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): THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. NO ANOMALIES FOUND. EVALUATION SUMMARY (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA (B)(4) COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. (B)(4) STD REVIEW - NO ANOMALIES FOUND

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT RECEIVED AN APPROPRIATE SHOCK AND THERE WAS AN AUTOMATIC CARELINK TRANSMISSION SENT. THE FOLLOWING DAY THE PATIENT RECEIVED ANOTHER APPROPRIATE SHOCK AND THIS WAS NOT TRANSMITTED AS THE ALERT CRITERION HAD BEEN MET AND THE DEVICE HAD NOT BEEN CLEARED. IT WAS ALSO REPORTED THE PATIENT COULD NOT HEAR THE DEVICE ALERT. 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 89 YR Other 6947 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD| 4194 IMPLANTABLE PACING LEAD