BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTRUST AT

    MDR report key: 2202099 · Received August 11, 2011

    Report

    Report Number
    6000144-2011-03871
    Event Type
    Injury
    Date Received
    August 11, 2011
    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
    IA, 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) THE DEVICE WAS RETURNED AND ANALYZED. THE BATTERY DEPLETION WAS WITHIN NORMAL LIMITS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS POSSIBLE PREMATURE BATTERY DEPLETION, AND THE ELECTIVE REPLACEMENT INDICATOR (ERI) FAILED TO DISPLAY ON THE DAY OF DEVICE CHANGEOUT. THE DEVICE WAS REPLACED. THERE WERE NO REPORTED PATIENT COMPLICATIONS 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 74 YR Hospitalization| R 6949 IMPLANTABLE TACHY LEAD| 3830 IMPLANTABLE PACING LEAD