BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 2131926 · Received June 16, 2011

    Report

    Report Number
    6000144-2011-03512
    Event Type
    Injury
    Date Received
    June 16, 2011
    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
    CO, US
    Reporter Occupation
    PHYSICIAN

    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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. EVALUATION SUMMARY: (B)(4) WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. BATTERY DEPLETION WAS INDICATED AS ELECTIVE REPLACEMENT INDICATOR (ERI) DUE TO HIGH BATTERY IMPEDANCE LOGGED ON (B)(4)-2011, PRIOR TO EXPLANT. RAMWARE VERSION 8 INSTALLED ON (B)(4)-2011. ADDITIONALLY, THE HIGH BATTERY IMPEDANCE LEAD TO ERI.

    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. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. BATTERY DEPLETION WAS INDICATED AS ELECTIVE REPLACEMENT INDICATOR (ERI) DUE TO HIGH BATTERY IMPEDANCE LOGGED ON (B)(6) 2011, PRIOR TO EXPLANT. RAMWARE VERSION 8 INSTALLED ON (B)(6) 2011. ADDITIONALLY, THE HIGH BATTERY IMPEDANCE LEAD TO ERI.

    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) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. BATTERY DEPLETION WAS INDICATED AS ELECTIVE REPLACEMENT INDICATOR (ERI) DUE TO HIGH BATTERY IMPEDANCE LOGGED ON (B)(6) 2011, PRIOR TO EXPLANT. RAMWARE VERSION 8 INSTALLED ON (B)(6) 2011. ADDITIONALLY, THE HIGH BATTERY IMPEDANCE LEAD TO ERI.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE TRIPPED ERI (ELECTIVE REPLACEMENT INDICATOR) DUE TO BATTERY IMPEDANCE CRITERIA. IT WAS NOTED THAT THE DEVICE WAS LOADED WITH THE PROGRAMMER AND FOUND TO HAVE A GOOD BATTERY VOLTAGE AND THEN SOME TIME LATER THE DEVICE WAS INTERROGATED AND FOUND TO BE AT ERI (ELECTIVE REPLACEMENT INDICATOR). THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE TRIPPED ERI (ELECTIVE REPLACEMENT INDICATOR) DUE TO BATTERY IMPEDANCE CRITERIA. IT WAS NOTED THAT THE DEVICE WAS LOADED WITH THE PROGRAMMER AND FOUND TO HAVE A GOOD BATTERY VOLTAGE AND THEN SOME TIME LATER THE DEVICE WAS INTERROGATED AND FOUND TO BE AT ERI (ELECTIVE REPLACEMENT INDICATOR). IT WAS FURTHER REPORTED THAT THE DEVICE WAS REMOVED 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 IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. P1501DR ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| O| R 5076 X2 IMPLANTABLE PACING LEAD| 5076 X2 IMPLANTABLE PACING LEAD| 5076 X2 IMPLANTABLE PACING LEAD