BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTRUST AT

    MDR report key: 1072595 · Received July 10, 2008

    Report

    Report Number
    2647346-2008-00343
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    May 12, 2008
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    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. EVALUATION SUMMARY: NO ANOMALIES WERE FOUND; FULL LEAD WAS RETURNED FOR ANALYSIS. ANALYSIS CONFIRMED THE REPORTED OVERSENSING CONDITION. ANALYSIS REVEALED THAT THE CAUSE OF THE OVERSENSING WAS EXCESSIVE LEAKGE IN A CAPACITOR CAUSED BY AN ASYMMETRICAL ANODE ISOLATION CUT.

    Description of Event or Problem · 1

    ASKU

    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 Required Intervention