BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 2810411 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-05878
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    February 16, 2012
    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
    FL, 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) - WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. A POWER ON RESET OCCURRED. DEVICE EXPERIENCED A CRITICAL RAM PARITY ERROR POR ON (B)(4) 2012 IN LOCATION "0E E2", AND LOCATION "22 E5." DEVICE SHOULD BE ABLE TO RECOVER FROM THE EVENT AND CONTINUE NORMAL FUNCTION. RADIATION THERAPY NOTED. THE DEVICE WAS RETURNED AND ANALYZED. 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 THE DEVICE HAD TWO PARITY ERRORS AND A POWER ON RESET, AND THE DEVICE WAS FOUND TO HAVE ELEVATED OUTPUTS DUE TO THE RESET. IT WAS NOTED THAT THE PATIENT IS UNDERGOING RADIATION THERAPY. IT WAS FURTHER NOTED THAT THE BATTERY VOLTAGE TREND HAS A LOT OF VARIATION. THE OUTPUTS WERE PROGRAMMED LOWER AND THE DEVICE WAS MONITORED MONTHLY. THE DEVICE WAS SUBSEQUENTLY EXPLANTED AND REPLACED DUE TO ELECTIVE REPLACEMENT INDICATOR. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R 5076 X2 IMPLANTABLE PACING LEADS