BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 2790274 · Received October 15, 2012

    Report

    Report Number
    6000144-2012-05701
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    June 28, 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
    IA, 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) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. DEVICE EXPERIENCED A CRITICAL RAM PARITY ERROR POWER ON RESET (POR) ON (B)(6) 2012 IN LOCATION "10 EF". DEVICE SHOULD BE ABLE TO RECOVER FROM THE EVENT AND CONTINUE NORMAL FUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE DEVICE CHECK THE DEVICE WAS AT VVI65 AND IT WAS NOTED THAT THE DEVICE HAD A CRITICAL RAM PARITY ERROR AND POWER ON RESET. IT WAS ALSO NOTED THAT A SOFTWARE UPDATE WAS INSTALLED THAT DAY AND THE BATTERY VOLTAGE MEASUREMENT WAS BELOW THE ELECTIVE REPLACEMENT INDICATOR (ERI) VOLTAGE. A REMOTE TRANSMISSION REPORT WILL BE DONE IN FIVE DAYS TO SEE IF ERI IS REACHED. THE DEVICE WAS REPROGRAMMED AND REMAINS IN USE. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 97 YR Required Intervention 5076 X2 IMPLANTABLE PACING LEADS