BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENRHYTHM DR

    MDR report key: 1864801 · Received October 12, 2010

    Report

    Report Number
    6000144-2010-05248
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    August 2, 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
    OH, 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. 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. LOW TELEMETERED BATTERY VOLTAGE - ON 01-AUG-2010, THE TELEMETERED BATTERY VOLTAGE WAS 2.57 V WHILE THE DAILY BATTERY VOLTAGE TREND MEASUREMENT WAS 2.86 V.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE BATTERY VOLTAGE (BV) READING ON THE CARELINK REPORT WAS 2.57 V, BUT THERE WAS NO ELECTIVE REPLACEMENT INDICATOR (ERI) MESSAGE NOTED. 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 90 YR Other 4076-2 IMPLANTABLE PACING LEAD| 4076-1 IMPLANTABLE PACING LEAD