BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 2203374 · Received August 11, 2011

    Report

    Report Number
    6000144-2011-04329
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    January 15, 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
    VA, 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. EVALUATION SUMMARY: (B)(4) 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. A POWER ON RESET WAS NOTED WITH A CRITICAL RAM PARITY ERROR LOGGED ON (B)(6) 2011 IN ADDRESS "0F DD". POR SEVERITY IS CONSIDERED LOW AS DEVICE SHOULD BE ABLE TO FULLY RECOVER AFTER RESET. IT WAS ALSO FOUND THAT THE BATTERY VOLTAGE HAD NO ANOMALIES AND THE DEVICE HAS NOT TRIPPED ELECTIVE REPLACEMENT INDICATOR.

    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. A POWER ON RESET WAS NOTED WITH A CRITICAL RAM PARITY ERROR LOGGED ON (B)(6) 2011 IN ADDRESS (B)(6). POR SEVERITY IS CONSIDERED LOW AS DEVICE SHOULD BE ABLE TO FULLY RECOVER AFTER RESET. IT WAS ALSO FOUND THAT THE BATTERY VOLTAGE HAD NO ANOMALIES AND THE DEVICE HAS NOT TRIPPED ELECTIVE REPLACEMENT INDICATOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE SHOWED POSSIBLE ELECTIVE REPLACEMENT INDICATOR (ERI) ON THE TRANSTELEPHONIC MONITOR AND WAS CLEARED. IT WAS QUESTIONED AS TO WHETHER IT WAS ERI OR AN ELECTRICAL RESET THAT WAS SHOWN ON THE MONITOR. THE DEVICE WAS REPROGRAMMED 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 THE DEVICE SHOWED POSSIBLE ELECTIVE REPLACEMENT INDICATOR (ERI) ON THE TRANSTELEPHONIC MONITOR AND WAS CLEARED. IT WAS QUESTIONED AS TO WHETHER IT WAS ERI OR AN ELECTRICAL RESET THAT WAS SHOWN ON THE MONITOR. THE DEVICE WAS REPROGRAMMED. IT WAS FURTHER REPORTED THAT THE DEVICE WAS EXPLANTED 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 81 YR Hospitalization| R 5076 X 2 IMPLANTABLE PACING LEAD| 5076 X 2 IMPLANTABLE PACING LEAD| 5076 X 2 IMPLANTABLE PACING LEAD