BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENRHYTHM DR

    MDR report key: 1926337 · Received December 14, 2010

    Report

    Report Number
    6000144-2010-06412
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S38
    Removal / Correction Number
    Z-1440-2010
    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. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY : (B)(4): PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND REVEALED LOW TELEMETERED BATTERY VOLTAGE. FURTHER ANALYSIS REVEALED THAT ON (B)(6) 2010, THE TELEMETERED BATTERY VOLTAGE WAS 2.54 V WHILE THE DAILY BATTERY VOLTAGE TREND MEASUREMENT WAS 2.92 V.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY VOLTAGE WAS READING 2.54 VOLTS, BUT ELECTIVE REPLACEMENT INDICATOR HAD NOT TRIGGERED. THE 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 ENRHYTHM DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. P1501DR ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other 5076 IMPLANTABLE PACING LEAD| (B)(4) COMPETITOR IMPLANTABLE PACING LEAD