BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTRUST AT

    MDR report key: 2289424 · Received October 12, 2011

    Report

    Report Number
    6000144-2011-05547
    Event Type
    Malfunction
    Date Received
    October 12, 2011
    Date of Event
    June 8, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S46
    Removal / Correction Number
    Z-1172-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, 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. ONE POWER ON RESET (POR) FOR CRITICAL RAM PARITY ERROR, ADDR 1B52, DATA CE, OCCURRED ON (B)(6) 2011 09:41:39. ONE PATIENT ALERT FOR DEVICE CIRCUIT ERROR OCCURRED ON (B)(6) 2011 09:41:39. THE DIAGNOSTIC INFORMATION IS CONSISTENT WITH THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD AN ELECTRICAL RESET. NO CHANGES WERE MADE IN PARAMETERS. 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 ENTRUST AT IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D154ATG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other 5076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD| 620BG27 HEART BAND