BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSULTA CRT-D

    MDR report key: 2203760 · Received August 11, 2011

    Report

    Report Number
    6000144-2011-04566
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S084
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, 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. NO ANOMALIES WERE FOUND. ALTHOUGH THE SAVE TO DISK SHOWED NO ANOMALIES, TECH SERVICES CONFIRMED THAT ELECTROGRAMS FOR THE DEVICE SHOWED THE ISSUE IN (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE STORED ELECTROGRAMS AND MARKERS ARE NOT PLOTTED PROPERLY. DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSULTA CRT-D IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. D224TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other 4068 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD| 4194 IMPLANTABLE PACING LEAD