BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTRUST AT

    MDR report key: 1875141 · Received October 19, 2010

    Report

    Report Number
    6000144-2010-05446
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    November 23, 2009
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S46
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. CRITICAL RAM PARITY ERROR NOTED ON (B)(6) 2009. POR (POWER ON RESET) SEVERITY: LOW. THE DEVICE SHOULD BE ABLE TO FULLY RECOVER AFTER THE RESET.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CORRECTION: CHANGE MADE TO DEVICE CONCLUSION. DEVICE CODE CHANGED. 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 NOTED ON (B)(6) 2009. POR (POWER ON RESET) SEVERITY: LOW. THE DEVICE SHOULD BE ABLE TO FULLY RECOVER AFTER THE RESET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE EXPERIENCED AN ELECTRICAL RESET. 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 58 YR Other 6943 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 6943 IMPLANTABLE TACHY LEAD