BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENRHYTHM DR

    MDR report key: 1861755 · Received October 8, 2010

    Report

    Report Number
    6000144-2010-04849
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    July 12, 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
    IL, 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 12-JUL-2010, THE TELEMETERED BATTERY VOLTAGE WAS 2.48 V WHILE THE DAILY BATTERY TREND VOLTAGE WAS 2.88 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. 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)(6) 2010, THE TELEMETERED BATTERY VOLTAGE WAS 2.48 V WHILE THE DAILY BATTERY TREND VOLTAGE WAS 2.88 V.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY VOLTAGE MEASUREMENT WAS LOW AND THERE WAS NO ELECTIVE REPLACEMENT INDICATOR MESSAGE. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS LATER REPORTED THAT DURING A SUBSEQUENT FOLLOW-UP THE PATIENT'S DEVICE WAS AGAIN PRODUCING A LOW BATTERY MEASUREMENT. THE DEVICE IS STILL IN USE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY VOLTAGE MEASUREMENT WAS LOW AND THERE WAS NO ELECTIVE REPLACEMENT INDICATOR MESSAGE. 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 ASKU DXY MEDTRONIC MED REL, INC. P1501DR ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other 5076-52 IMPLANTABLE PACING LEAD| 5076-52 IMPLANTABLE PACING LEAD| 5076-45 IMPLANTABLE PACING LEAD| 5076-45 IMPLANTABLE PACING LEAD