BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTA XT VR

    MDR report key: 2811907 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-06100
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 10, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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: (B)(4). THE DEVICE WAS RETURNED AND ANALYSIS FOUND NO ANOMALIES. HOWEVER, THE SET SCREW WAS LOOSE/DETACHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE IMPLANT PROCEDURE, THE DEVICE SETSCREW WOULD NOT RESEAT AFTER HAVING TO REPOSITION A LEAD. IT WAS ALSO REPORTED THAT A TRANSVENE LEAD WAS ATTEMPTED AND WAS DAMAGED DUE TO THE PATIENT'S ANATOMY. THE DEVICE AND LEAD WERE NOT USED AND ANOTHER DEVICE AND LEAD WERE IMPLANTED. 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 VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D314VRM

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other