BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 1854718 · Received October 5, 2010

    Report

    Report Number
    6000144-2010-04444
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    August 16, 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. CORRECTED OTHER DEVICES. 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 2.17 V WHILE THE DAILY BATTERY VOLTAGE TREND MEASUREMENT WAS 2.85 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 2.17 V WHILE THE DAILY BATTERY VOLTAGE TREND MEASUREMENT WAS 2.85 V.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTERROGATED BATTERY VOLTAGE WAS 2.17 V, BUT REVIEW OF DEVICE DATA SHOWED AN AVERAGE BATTERY VOLTAGE OVER THE LAST 14 DAYS OF 2.85 V. THE DEVICE WAS EXPLANTED AND REPLACED. IT WAS FURTHER REPORTED THAT THE ATRIAL LEAD HAD CHRONIC HIGH THRESHOLDS. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTERROGATED BATTERY VOLTAGE WAS 2.17 V, BUT REVIEW OF DEVICE DATA SHOWED AN AVERAGE BATTERY VOLTAGE OVER THE LAST 14 DAYS OF 2.85 V. THE DEVICE WAS EXPLANTED AND REPLACED. 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 84 YR Required Intervention 4076 (X2) IMPLANTABLE PACING LEADS