BEUDAMED
    FDA Adverse Event Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 1864960 · Received October 12, 2010

    Report

    Report Number
    6000144-2010-05226
    Date Received
    October 12, 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
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. ANALYSIS CONCLUDED THAT THE DEVICE EXPERIENCED A MEMORY PROBLEM. THE LEAD AND BATTERY TRENDS ARE NOT DISPLAYING IN THE ANALYSIS FILE. UPON FURTHER ANALYSIS IT WAS OBSERVED THAT THE TRENDS HAVE AN "INVALID TYPE" INDICATOR, A DOUBLE BIT FLIP MEMORY ERROR IN THE LEAD OR BATTERY TREND DATA. A POWER ON RESET WAS NOT TRIGGERED. CORRECTED DATA: PATIENT DATE OF DEATH AND REMOVED DEVICE REMAINS ACTIVATED DEVICE CODE.

    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 THAT PATIENT CARELINK TRANSMISSION SHOWS NO LEAD TRENDS AND A MESSAGE SHOWS ABOUT INVALID DATA. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ASKU

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCERTO CRT-D DR ASKU NIK MEDTRONIC MED REL, INC. C154DWK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 4194 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| 6949 IMPLANTABLE TACHY LEAD| 4194 IMPLANTABLE PACING LEAD