BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTRUST AT

    MDR report key: 2131893 · Received June 16, 2011

    Report

    Report Number
    6000144-2011-03543
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    February 8, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S46
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS 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. NOISE - INTERFERENCE/NOISE- HIGH V-SIC COUNTS ARE OBSERVED WITH 4956 COUNTS OCCURRING SINCE THE (B)(6) 2010. HIGH SIC CAN INDICATE THE PRESENCE OF NOISE OR INTERMITTENCY IN THE SYSTEM.- SENSING - OVERSENSING- MULTIPLE SHORT V-V SENSED EVENTS OF < 220 MS ARE OBSERVED ON THE (B)(6) 2010. (14 EPISODES NST, 9 EPISODES VF) POWER ON RESET - POWER ON RESET PARAMETERS- CRITICAL RAM PARITY ERROR RECORDED ON (B)(6) 2010 AT ADDRESS 11 D2. POR SEVERITY: LOW. THE DEVICE SHOULD BE ABLE TO FULLY RECOVER AFTER THE RESET.

    Description of Event or Problem · 1

    THE SAVE TO DISK WAS RETURNED TO THE MANUFACTURER AND ANALYZED. THE DATA ANALYSIS REVEALED THAT THE DEVICE WAS SUBSEQUENTLY OUT OF SPECIFICATION. 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 87 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD