BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3153723 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06199
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    March 21, 2013
    Report Date
    September 30, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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: 5076-52, IMPLANTABLE PACING LEAD, (B)(6) 2013; ADDR01, IMPLANTABLE PULSE GENERATOR (IPG), (B)(6) 2013. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DAY POST IMPLANT, A PERFORATION OF THE RIGHT VENTRICULAR (RV) LEAD WAS SUSPECTED AS A PERICARDIAL RUB WAS HEARD BY AUSCULTATION. THERE WAS NO PERICARDIAL EFFUSION AND THE LEAD THRESHOLDS WERE STABLE. THE RV LEAD WAS REPOSITIONED TO THE SEPTAL WALL AND REMAINS IN USE. IT WAS FURTHER REPORTED THAT THE ATRIAL LEAD HAD DISLODGED AND WAS IN THE VENTRICLE. THE PATIENT ONLY HAS FEW SECOND PAUSES DUE TO A TRANSITION FROM ATRIAL FIBRILLATION TO NORMAL SINUS RHYTHM SO THE PHYSICIAN ELECTED TO REMOVE THE ATRIAL LEAD AND NOT REPLACE IT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254794 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00087 YR Hospitalization| R