BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTA XT DR

    MDR report key: 2811190 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-05950
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 7, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S211
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 DURING THE IMPLANT PROCEDURE, THERE WAS DIFFICULTY INSERTING THE RV (RIGHT VENTRICULAR) LEAD INTO THE PORT. AFTER FIVE ATTEMPTS, THE LEAD WAS SUCCESSFULLY INSERTED. THE DEVICE REMAINS IN USE. NO 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 DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D314DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other 4086 IMPLANTABLE PACING LEAD| 0158 COMPETITOR IMPLANTABLE TACHY LEAD