BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 2790807 · Received October 15, 2012

    Report

    Report Number
    6000144-2012-05614
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    August 17, 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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION SUMMARY: 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.

    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 FOR (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 REVEALED POWER ON RESET (POR) PARAMETERS AND THAT DEVICE EXPERIENCED A CRITICAL RAM PARITY ERROR POR ON 17 AUG 2012 IN LOCATION "1C 8C" AND 21 AUG 2012 IN LOCATION "0E 78". DEVICE SHOULD BE ABLE TO RECOVER FROM THE EVENT AND CONTINUE NORMAL FUNCTION. EVIDENCE OF RADIATION THERAPY CONCOMITANT WITH EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE PATIENT HAD RADIATION THERAPY THE DEVICE HAD TWO POWER ON RESETS (POR) WHICH CLEARED THE DIAGNOSTICS AND CHANGED THE DEVICE SETTINGS. THE POR ALSO REMOVED A SOFTWARE UPDATE SO THAT WHEN THE DEVICE WAS INTERROGATED IT SHOWED A MESSAGE THAT "ERI (ELECTIVE REPLACEMENT INDICATOR) IS IMMINENT". THE SOFTWARE WAS RELOADED AND THE DEVICE SETTINGS WERE REPROGRAMMED. 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 LATER REPORTED THAT THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENRHYTHM DR PULSE GENERATOR, PERMANENT, IMPLANTABLE DXY MEDTRONIC MED REL, INC. P1501DR

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R 5076 X2 IMPLANTABLE PACING LEADS