BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTRUST AT

    MDR report key: 2785346 · Received October 12, 2012

    Report

    Report Number
    6000094-2012-01993
    Event Type
    Malfunction
    Date Received
    October 12, 2012
    Date of Event
    July 13, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S46
    Removal / Correction Number
    Z-1172-2009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. 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. POWER ON RESET (POR) PARAMETERS WERE NOTED AS ONE POR FOR CRITICAL RAM PARITY ERROR, ADDR=14A2, DATA=FD OCCURRED ON (B)(6) 2012 02:28:48. ONE PATIENT ALERT FOR DEVICE CIRCUIT ERROR OCCURRED ON (B)(6) 2012 02:28:48.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CARELINK TRANSMISSION REVEALED A POWER ON RESET. THE DEVICE WAS REPROGRAMMED AND REMAINS IN USE. NO PATIENT COMPLICATIONS WERE 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 S.A. D154ATG

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other COMPETITOR IMPLANTABLE TACHY LEAD