BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3153439 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06026
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    April 1, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. A D314TRM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, (B)(6) 2012. A 6947M IMPLANTABLE TACHY LEAD, 2012. A 4195 IMPLANTABLE PACING LEAD, 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEADS BOTH HAD TO BE REVISED DUE TO THE PATIENT¿S TWIDDLER SYNDROME. THE RV LEAD WAS UNABLE TO BE REPOSITIONED SO IT WAS EXPLANTED AND REPLACED. THE RA LEAD WAS DISLODGED AND WAS REPOSITIONED AND 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
    258986 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R