BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3153484 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06023
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 19, 2013
    Report Date
    April 2, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. CONCOMITANT PRODUCTS: PRODUCT ID 5076-45 IMPLANTABLE PACING LEAD (B)(6) 2013; SEDR01 IMPLANTABLE PULSE GENERATOR (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING POCKET STIMULATION WITH PACING OF THE ATRIAL LEAD. AN X-RAY WAS DONE AND SHOWED THE ATRIAL LEAD WAS DISLODGED AND COILED IN THE POCKET. X-RAY ALSO SHOWED THAT THE RIGHT VENTRICULAR (RV) LEAD SLACK WAS GONE. IT IS SUSPECTED THE PATIENT HAS TWIDDLER¿S SYNDROME. THE DEVICE WAS REPROGRAMMED AND THE PATIENT WILL BE SCHEDULED FOR A LEAD REVISION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256252 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Hospitalization| R