BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 1792347 · Received August 11, 2010

    Report

    Report Number
    6000144-2010-03225
    Event Type
    Injury
    Date Received
    August 11, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S38
    Removal / Correction Number
    Z-1440-2010
    Adverse Event
    Yes
    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. PERFORMANCE DATA COLLECTED FROM THE DEVICE SHOWED LOW TELEMETERED BATTERY VOLTAGE. ON (B)(6) 2010, THE BATTERY VOLTAGE WITH TELEMETRY WAS 2.54V AND THE DAILY MEASUREMENT WAS 2.89V.

    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. PERFORMANCE DATA COLLECTED FROM THE DEVICE SHOWED LOW TELEMETERED BATTERY VOLTAGE. ON (B)(6) 2010, THE BATTERY VOLTAGE WITH TELEMETRY WAS 2.54V AND THE DAILY MEASUREMENT WAS 2.89V.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4): CALCULATIONS BASED ON IMPLANT PARAMETERS INDICATE THAT THE DEVICE HAD MET ITS 99.9% EXPECTED LONGEVITY. ANALYSIS OF THE DEVICE MEMORY FOUND THE ERI (ELECTIVE REPLACEMENT INDICATOR) IS THE RESULT OF HIGH INTERNAL BATTERY RESISTANCE. THIS DEVICE IS PART OF THE FIELD ACTION AND HAS TESTED CONSISTENT WITH THE FIELD ACTION. PERFORMANCE DATA COLLECTED FROM THE DEVICE SHOWED LOW TELEMETERED BATTERY VOLTAGE. ON (B)(6) 2010, THE BATTERY VOLTAGE WITH TELEMETRY WAS 2.54V AND THE DAILY MEASUREMENT WAS 2.89V.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IN OFFICE BATTERY VOLTAGE WAS 2.54V AND THE DEVICE'S DAILY MEASURED BATTERY VOLTAGE WAS 2.89V ON (B)(6), 2010. IT WAS FURTHER REPORTED THAT THE BATTERY VOLTAGE WAS 2.14 V IN THE OFFICE. REVIEW OF DEVICE DATA SHOWED THE VOLTAGE TO RANGE FROM 2.76 TO 2.97 V. THE DEVICE REMAINS IN USE. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IN OFFICE BATTERY VOLTAGE WAS 2.54V AND THE DEVICE'S DAILY MEASURED BATTERY VOLTAGE WAS 2.89V ON (B)(6) 2010. IT WAS FURTHER REPORTED THAT THE BATTERY VOLTAGE WAS 2.14 V IN THE OFFICE. REVIEW OF DEVICE DATA SHOWED THE VOLTAGE TO RANGE FROM 2.76 TO 2.97 V. THE DEVICE REMAINS IN USE. IT WAS LATER REPORTED THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) JUST (B)(6) AFTER A DEVICE CHECK IN THE CLINIC. IT WAS SUSPECTED THE DEVICE HAD EARLY BATTERY DEPLETION DUE TO HIGH BATTERY IMPEDANCE. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IN OFFICE BATTERY VOLTAGE WAS 2.54V AND THE DEVICE'S DAILY MEASURED BATTERY VOLTAGE WAS 2.89V ON (B)(6) 2010. 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 Hospitalization| O| R 5076 (X2) IMPLANTABLE PACING LEADS| 5076 (X2) IMPLANTABLE PACING LEADS| 5076 (X2) IMPLANTABLE PACING LEADS