BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENRHYTHM DR

    MDR report key: 1854962 · Received October 5, 2010

    Report

    Report Number
    6000144-2010-04338
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    August 11, 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
    AL, 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. ON (B)(4) 2010, THE TELEMETERED BATTERY VOLTAGE WAS 2.75 V, WHILE THE DAILY BATTERY VOLTAGE TREND MEASUREMENT WAS 2.95 V.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY VOLTAGE WAS 2.78 V, BUT THE BATTERY VOLTAGE IS NOW 2.65 V. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY VOLTAGE WAS 2.78 V, BUT THE BATTERY VOLTAGE IS NOW 2.65 V. IT WAS FURTHER REPORTED THAT THE IN-OFFICE READING WAS 2.69 V, BUT REVIEW OF DEVICE DATA SHOWED A RANGE OF 2.93 TO 2.95 V. 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 ASKU DXY MEDTRONIC MED REL, INC. P1501DR ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other 4074 IMPLANTABLE PACING LEAD| 4592 IMPLANTABLE PACING LEAD| 4592 IMPLANTABLE PACING LEAD| 4074 IMPLANTABLE PACING LEAD