BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3862069 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07063
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 28, 2014
    Report Date
    March 28, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. CONCOMITANT MEDICAL PRODUCTS: 5554-53, LEAD, IMPLANTED: (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE RIGHT VENTRICULAR (RV) LEAD INITIAL POSITION HAD HIGH THRESHOLD. THE PHYSICIAN MOVED THE LEAD AND WHILE SCREWING THE LEAD BACK IN THE LEAD BOUNCED AND DROPPED OFF FROM THE MYOCARDIUM. DURING IMPLANTATION OF THE LEAD THE PATIENT COMPLAINED OF FEELING SUFFOCATED. POST OPERATIVELY IT WAS DISCOVERED THAT A PERFORATION OCCURRED AND THERE WERE PERICARDIAL EFFUSIONS. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR TREATMENT. THE RV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342303 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Hospitalization| L| R ADDRS1, IPG