BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT VR

    MDR report key: 2790104 · Received October 15, 2012

    Report

    Report Number
    6000144-2012-05585
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S211
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 HAD ATRIAL FIBRILLATION WHICH CAUSED A RAPID VENTRICULAR RESPONSE. THE DEVICE HAD POOR RATE CONTROL AND DELIVERED INAPPROPRIATE THERAPY. THE PATIENT HAD AN ATRIO-VENTRICULAR JUNCTION ABLATION AND THE DEVICE WAS EXPLANTED AND REPLACED. IT WAS NOTED THAT THE PATIENT IS TAKING PART IN THE SYSTEM LONGEVITY STUDY. 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 PROTECTA XT VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D314VRG

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L| R 6935 IMPLANTABLE TACHY LEAD