BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENPULSE

    MDR report key: 2061625 · Received April 18, 2011

    Report

    Report Number
    2647346-2011-00563
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S032
    Removal / Correction Number
    ASKU
    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.

    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. IT WAS NOTED THAT THE 75,000 ATRIAL HIGH RATE EPISODES HAD USED UP DEVICE MEMORY AS THE MEMORY HAD NOT BEEN CLEARED AS THE PATIENT HAD NOT BEEN FOLLOWED FOR GREATER THAN ONE YEAR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL HIGH RATES WERE POSSIBLY THE RESULT OF FAR FIELD R WAVE OVERSENSING. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENPULSE IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. E2DR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Other (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACING LEAD