BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENRHYTHM DR

    MDR report key: 1874620 · Received October 19, 2010

    Report

    Report Number
    6000144-2010-05394
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    July 1, 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
    TN, 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. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL.

    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 THIS DEVICE WAS ANALYZED AND REVEALED THERE WAS A LOW TELEMETERED BATTERY VOLTAGE. ON (B)(6) 2010 THE TELEMETERED BATTERY VOLTAGE WAS 2.61 V WHILE THE DAILY BATTERY VOLTAGE TREND MEASUREMENT WAS 2.90 V. ALSO, THE SERIAL NUMBER IN THE FILE IS RECORDED AS ALL ZEROES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN (B)(6), LOW BATTERY VOLTAGES OF 2.61V AND 2.24V WERE NOTED DURING THE SAME FOLLOW-UP, ALSO THAT A BATTERY VOLTAGE OF 2.72V WAS NOTED ON (B)(6), AND 2.61V ON (B)(6). THERE IS NO ELECTIVE REPLACEMENT INDICATOR (ERI). THE CALLER IS CONCERNED ABOUT BATTERY STATUS. 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 85 YR Other 5076 IMPLANTABLE PACING LEAD X2| 5076 (X2) IMPLANTABLE PACING LEAD