BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 1924072 · Received December 14, 2010

    Report

    Report Number
    6000144-2010-06082
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    September 1, 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
    KY, 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. THE PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND REVEALED LOW TELEMETERED BATTERY VOLTAGE. ON (B)(6) 2010, THE TELEMETERED BATTERY VOLTAGE WAS 2.48 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 PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND REVEALED LOW TELEMETERED BATTERY VOLTAGE. ON (B)(6) 2010, THE TELEMETERED BATTERY VOLTAGE WAS 2.48 V WHILE THE DAILY BATTERY VOLTAGE TREND MEASUREMENT WAS 2.85 V. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE PATIENT'S PAST TWO DOCTOR VISITS THE DEVICE BATTERY WAS READING BELOW THE ELECTIVE REPLACEMENT INDICATOR (ERI) POINT, BUT HAD NOT YET TRIGGERED ERI. IT WAS ALSO REPORTED THAT APPROXIMATELY THREE WEEKS LATER AT A SUBSEQUENT DOCTOR VISIT, THE DEVICE WAS STILL READING BELOW THE ERI POINT, BUT HAD NOT YET TRIGGERED ERI. HOWEVER, IT WAS REPORTED THAT THE DEVICE'S NIGHTLY REPORTED BATTERY READINGS OVER THE TWO WEEKS PRECEDING THE LAST DOCTOR VISIT WERE ABOVE THE ERI POINT. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE PATIENT'S PAST TWO DOCTOR VISITS THE DEVICE BATTERY WAS READING BELOW THE ELECTIVE REPLACEMENT INDICATOR (ERI) POINT BUT HAD NOT YET TRIGGERED ERI. IT WAS ALSO REPORTED THAT APPROXIMATELY (B)(6) LATER AT A SUBSEQUENT DOCTOR VISIT, THE DEVICE WAS STILL READING BELOW THE ERI POINT BUT HAD NOT YET TRIGGERED ERI. HOWEVER, IT WAS REPORTED THAT THE DEVICE'S NIGHTLY REPORTED BATTERY READINGS OVER THE (B)(6) PRECEDING THE LAST DOCTOR VISIT WERE ABOVE THE ERI POINT. IT WAS FURTHER REPORTED THAT THE DEVICE REACHED ERI AND WAS 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 IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. P1501DR ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| O| R (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACING LEAD