BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3990261 · Received August 7, 2014

    Report

    Report Number
    2649622-2014-08708
    Event Type
    Injury
    Date Received
    August 7, 2014
    Report Date
    May 15, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 PRODUCT: PRODUCT ID 5076-52, CRDM NON DEFIB LEAD, IMPLANTED (B)(6) 2007. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON FLUOROSCOPY THE RIGHT ATRIAL (RA) LEAD LOOKS LIKE IT WAS PLACED VERY LATERAL AND THE LEAD TIP MAY NOT BE DEEP IN THE ATRIAL MUSCLE. IMPEDENCE IS HIGH AND HAS BEEN RISING AND A SCAR MAY HAVE BEEN FORMING AT THE LEAD / TISSUE INTERFACE. THE LEAD WAS STARTING TO SHOW SOME NOISE ON THE ATRIAL CHANNEL AS WELL AS INAPPROPRIATE MODE SWITCHING. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463242 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Hospitalization| R P1501DR IMPLANTABLE PULSE GENERATOR (IPG)