BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTRUST AT

    MDR report key: 2201759 · Received August 11, 2011

    Report

    Report Number
    6000144-2011-03807
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    March 28, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    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
    CA, 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): EVALUATION SUMMARY: (B)(4) THE DEVICE WSA RETURNED, ANALYZED, AND ANALYSIS RESULTS REVEALED NORMAL BATTERY DEPLETION. THE DEVICE MEETS EXPECTED LONGEVITY. PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS REVEALED A POWER ON RESET OF THE PARAMETERS. THERE WERE TWO PORS FOR CRITICAL RAM PARITY ERROR, ADDR=1204, DATA=C1, ON (B)(6) 2011 16:48:41 AND ADDR=1008, DATA=40, ON (B)(6) 2011 15:55:47 AND ONE PATIENT ALERT FOR DEVICE CIRCUIT ERROR ON (B)(6) 2011 15:55:47. (B)(4): THE DEVICE WAS RETURNED AND ANALYSIS FOUND NORMAL DEPLETION.

    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): INITIALLY, THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION, HOWEVER PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS REVEALED A POWER ON RESET OF THE PARAMETERS. THERE WERE TWO PORS FOR CRITICAL RAM PARITY ERROR, ADDR=1204, DATA=C1, ON (B)(6) 2011 16:48:41 AND ADDR=1008, DATA=40, ON (B)(6) 2011 15:55:47 AND ONE PATIENT ALERT FOR DEVICE CIRCUIT ERROR ON (B)(6) 2011 15:55:47. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE PATIENT WAS RECEIVING THERAPEUTIC RADIATION, AN ELECTRICAL RESET OF THE DEVICE OCCURRED. THE PROGRAMMED SETTINGS OF THE DEVICE WENT TO THE RESET SETTINGS AND THE DEVICE DELIVERED SHOCKS DUE TO ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. LATER AT INTERROGATION, THE DEVICE "CHECKED OUT FINE" AND FOLLOW-UP DETERMINED THAT THE DEVICE WAS NOT REPROGRAMMED. THE DEVICE WAS EXPLANTED AND RETURNED TO THE MANUFACTURER. NO FURTHER 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 78 YR Hospitalization| L| O| R 6944 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 6944 IMPLANTABLE TACHY LEAD