BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 1861584 · Received October 8, 2010

    Report

    Report Number
    6000144-2010-04793
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    July 6, 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
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ANALYSIS RESULTS REVEALED THE PRESENCE OF POWER ON RESET (POR) PARAMETERS. ON 06 JUL 2010 CRITICAL RANDOM ACCESS MEMORY (RAM) PARITY ERROR OCCURRED. THE POR SEVERITY LEVEL IS LOW. THE DEVICE SHOULD BE ABLE TO FULLY RECOVER AFTER THE RESET.

    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): ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ANALYSIS RESULTS REVEALED THE PRESENCE OF POWER ON RESET (POR) PARAMETERS. ON (B)(4) 2010 CRITICAL RANDOM ACCESS MEMORY (RAM) PARITY ERROR OCCURRED. THE POR SEVERITY LEVEL IS LOW. THE DEVICE SHOULD BE ABLE TO FULLY RECOVER AFTER THE RESET.

    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): 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. ANALYSIS RESULTS REVEALED THE PRESENCE OF POWER ON RESET (POR) PARAMETERS. ON (B)(6) 2010 CRITICAL RANDOM ACCESS MEMORY (RAM) PARITY ERROR OCCURRED. THE POR SEVERITY LEVEL IS LOW. THE DEVICE SHOULD BE ABLE TO FULLY RECOVER AFTER THE RESET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A POWER ON RESET OCCURRED AT THE SAME TIME THE PATIENT WAS TRANSMITTING DEVICE PERFORMANCE DATA FOR A REMOTE FOLLOW UP. IT WAS FURTHER REPORTED THAT THE DEVICE WAS EXPLANTED AND REPLACED DUE TO PREMATURE BATTERY DEPLETION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A POWER ON RESET OCCURRED AT THE SAME TIME THE PATIENT WAS TRANSMITTING DEVICE PERFORMANCE DATA FOR A REMOTE FOLLOW UP. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ASKU.

    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 85 YR Hospitalization| O| R 5092 IMPLANTABLE PACING LEAD| 5092 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 5092 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD