BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 2051267 · Received April 12, 2011

    Report

    Report Number
    6000144-2011-01520
    Event Type
    Injury
    Date Received
    April 12, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S38
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    PHYSICIAN

    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) PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED, AND REVEALED THAT THERE WERE 5 CRITICAL RAM PARITY ERRORS LOGGED FOR THIS DEVICE. THE PATIENT HAS BEEN RECEIVING RADIATION THERAPY, WHICH IS KNOWN TO BE ONE POTENTIAL CAUSE OF POWER ON RESETS. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS AT ERI (ELECTRICAL REPLACEMENT INDICATOR) AND COULD BE REPROGRAMMED. IT WAS LATER DETERMINED THAT THE DEVICE HAD ACTUALLY ELECTRICALLY RESET DUE TO RADIATION THERAPY. 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention 3830 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD