BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENRHYTHM DR

    MDR report key: 1863244 · Received October 9, 2010

    Report

    Report Number
    6000144-2010-05364
    Event Type
    Malfunction
    Date Received
    October 9, 2010
    Date of Event
    August 10, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S38
    Removal / Correction Number
    Z-1440-2010
    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. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. THE PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND THE DATA REVEALED LOW TELEMETERED BATTERY VOLTAGE. ON (B)(6), 2010, THE TELEMETERED BATTERY VOLTAGE WAS 2.50 V WHILE THE DAILY BATTERY VOLTAGE TREND MEASUREMENT WAS 2.86 V.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY VOLTAGE MEASURES 2.5V IN OFFICE VS. THE LAST MEASUREMENT ON THE DAILY TREND OF 2.86V. THE CALLER CALLED TECHNICAL SERVICES IN AN EFFORT TO UNDERSTAND THE TRUE BATTERY VOLTAGE. THE DEVICE REMAINS 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 ENRHYTHM DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. P1501DR ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other 5076 IMPLANTABLE PACING LEAD X2