BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3862267 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-06897
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    February 19, 2014
    Report Date
    March 10, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    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. CONCOMITANT MEDICAL PRODUCTS: A 6947M62 LEAD, IMPLANTED: (B)(6) 2014. A 429888 LEAD, IMPLANTED: (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD DISLODGED. IT WAS FURTHER REPORTED THAT THERE WAS ¿VENTRICULAR STIMULATION THAT WAS CORRECTED WITH ATRIAL LEAD¿. THE LEAD WAS REPOSITIONED AND REMAINS IN USE. THE PATIENT WAS ENROLLED IN THE PANORAMA 2 CLINICAL STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342960 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Hospitalization| R DTBA2QQ CRT-D