BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTA XT CRT-D

    MDR report key: 2953132 · Received February 9, 2013

    Report

    Report Number
    6000094-2013-00008
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    October 25, 2012
    Report Date
    December 3, 2012
    Manufacturer
    MEDTRONIC S.A. (SMO)
    Product Code
    LWS
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED MALFUNCTION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NOISY EPISODES ON THE RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) CHANNELS WERE NOTED FROM THE REMOTE MONITOR TRANSMISSION. IT WAS LATER REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE AND THE DEVICE'S DETECTION AND THERAPIES WERE LEFT ON BECAUSE THE PATIENT DID NOT INFORM THE HOSPITAL OF THEIR IMPLANTED DEVICE. 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
    56290 PROTECTA XT CRT-D LWS MEDTRONIC S.A. (SMO) D354TRM

    Patients

    Seq Age Sex Outcome Treatment
    1