BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTRUST AT

    MDR report key: 1922227 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-05899
    Event Type
    Injury
    Date Received
    December 13, 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
    IN, 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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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 LOST TELEMETRY AND FUNCTION DUE TO BATTERY DEPLETION. THE CAUSE OF THE DEPLETION CANNOT BE DETERMINED. THE DEVICE WAS FULLY FUNCTIONAL AND OPERATED UNDER NORMAL CURRENT DRAIN WHEN POWERED WITH AN EXTERNAL SUPPLY. THE RESIDUAL VOLTAGE AND IMPEDANCE INDICATES THAT THERE ARE NO BATTERY ISSUES. SINCE NO SAVE TO DISK DATA COULD BE RETRIEVED FROM THE DEVICE AND NO OTHER DATA WAS PROVIDED FROM THE FIELD THERE IS NO WAY TO CONFIRM THIS RESULT. THE RESULT OF ANALYSIS IS INCONCLUSIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS AT END OF LIFE, AND THE DEVICE COULD NOT BE INTERROGATED. IT WAS ALSO NOTED THAT THE PATIENT INDICATED THAT THEY HAD HEARD THE DEVICE BEEPING A WHILE AGO PRIOR TO DEVICE CHECK AND CHANGE OUT, BUT THAT IT HAD STOPPED. THE DEVICE WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS AT END OF LIFE, AND THE DEVICE COULD NOT BE INTERROGATED. THE DEVICE WAS REMOVED AND REPLACED. 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 MED REL, INC. D154ATG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R 6948 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD| 6948 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD