BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 1924379 · Received December 14, 2010

    Report

    Report Number
    6000144-2010-06126
    Event Type
    Injury
    Date Received
    December 14, 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
    TX, 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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. EVALUATION SUMMARY: (B)(4): PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND REVEALED A LOW TELEMETERED BATTERY VOLTAGE. ANALYSIS ALSO REVEALED ON (B)(6) 2010, THE TELEMETERED BATTERY VOLTAGE WAS 2.58 V WHILE THE DAILY BATTERY VOLTAGE TREND MEASUREMENT WAS 2.90 V. EVALUATION SUMMARY FROM ADDITION INFORMATION RECEIVED ON (B)(6) 2011: THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ANALYSIS OF THE DATA REVEALED A LOW TELEMETERED BATTERY VOLTAGE.

    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): PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND REVEALED A LOW TELEMETERED BATTERY VOLTAGE. ANALYSIS ALSO REVEALED ON (B)(6) 2010, THE TELEMETERED BATTERY VOLTAGE WAS 2.58 V WHILE THE DAILY BATTERY VOLTAGE TREND MEASUREMENT WAS 2.90 V. EVALUATION SUMMARY FROM ADDITION INFORMATION RECEIVED ON (B)(6) 2011: THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ANALYSIS OF THE DATA REVEALED A LOW TELEMETERED BATTERY VOLTAGE. 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 IMPEDANCE. THIS DEVICE IS PART OF THE FIELD ACTION AND HAS TESTED CONSISTENT WITH THE FIELD ACTION.

    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): PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND REVEALED A LOW TELEMETERED BATTERY VOLTAGE. ANALYSIS ALSO REVEALED ON (B)(6) 2010, THE TELEMETERED BATTERY VOLTAGE WAS 2.58 V WHILE THE DAILY BATTERY VOLTAGE TREND MEASUREMENT WAS 2.90 V.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY VOLTAGE ON TELEMETRY WAS LOWER THAN THE SAVE TO DISK VOLTAGE. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE DEVICE HAS REACHED THE ELECTIVE REPLACEMENT TIME AND WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT THE BATTERY VOLTAGE ON TELEMETRY WAS LOWER THAN THE SAVE TO DISK VOLTAGE. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. (B)(6) 2011 - IT WAS FURTHER REPORTED THAT THE DEVICE HAS REACHED THE ELECTIVE REPLACEMENT TIME AND WAS EXPLANTED 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 BATTERY VOLTAGE ON TELEMETRY WAS LOWER THAN THE SAVE TO DISK VOLTAGE. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE DEVICE HAS REACHED THE ELECTIVE REPLACEMENT TIME AND WAS EXPLANTED 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 BATTERY VOLTAGE ON TELEMETRY WAS LOWER THAN THE SAVE TO DISK VOLTAGE. 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 IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. P1501DR ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| O| R (B)(4) (X2) IMPLANTABLE PACING LEAD| (B)(4) (X2) IMPLANTABLE PACING LEAD| (B)(4) (X2) IMPLANTABLE PACING LEAD