BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENRHYTHM DR

    MDR report key: 2050774 · Received April 12, 2011

    Report

    Report Number
    6000144-2011-01485
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    January 21, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S38
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. 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. CRITICAL RAM PARITY ERROR OCCURRED ON (B)(4)-2011 IN ADDRESS "0E 58". POR (POWER ON RESET) SEVERITY CONSIDERED LOW AND DEVICE SHOULD BE ABLE TO FULLY RECOVER AFTER RESET. POR TIMESTAMP COINCIDED WITH UPDATE TO RAMWARE VERSION 8.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A POWER ON RESET OCCURRED. THE DEVICE 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Other 5076 X2 IMPLANTABLE PACING LEADS