BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTRUST AT

    MDR report key: 2811030 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-06295
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S46
    Removal / Correction Number
    Z-1172-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED SEVEN SHOCKS FOR ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. THE REMAINING LONGEVITY OF THE DEVICE WAS DISCUSSED. THE DEVICE IS STILL IN USE. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening| O 6931 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD