BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 2203210 · Received August 11, 2011

    Report

    Report Number
    6000144-2011-04160
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    March 20, 2011
    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
    WI, 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 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. POWER ON RESET (POR) PARAMETERS, CRITICAL RAM PARITY ERROR LOGGED ON (B)(6) 2011 IN ADDRESS (B)(6). POR SEVERITY IS CONSIDERED LOW AS DEVICE SHOULD BE ABLE TO FULLY RECOVER AFTER RESET. PATIENT WAS WELDING AT TIME OF POR. DEVICE WAS NOT RETURNED, BUT DIAGNOSTIC INFORMATION IS CONSISTENT WITH REPORTED EVENT. OPERATIONAL CONTEXT MAY HAVE ALSO APPLIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE EXPERIENCED AN ELECTRICAL RESET, WHICH APPEARED TO BE TYPICAL OF EXPOSURE TO A STRONG ELECTRICAL NOISE FROM WELDING. THE PATIENT HAD BEEN WELDING IN A TIGHT CORNER AT THE TIME OF RESET. THE RESET WAS CLEARED, AND 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 78 YR Required Intervention (B)(4) TISSUE VALVE| (B)(4) IMPLANTABLE PACING LEAD