BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3990086 · Received August 7, 2014

    Report

    Report Number
    2649622-2014-08811
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 6, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY - THE FULL LEAD WAS RETURNED AND ANALYZED 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 DURING AN INITIAL IMPLANT PROCEDURE THE PHYSICIAN HAD DIFFICULTY LOCATING A RIGHT VENTRICULAR (RV) LEAD POSITION WITH SUITABLE THRESHOLDS. THE LEAD WAS ALSO EXHIBITING HIGH IMPEDANCE LEVELS, AND LOW R-WAVES. AFTER SEVERAL ATTEMPTS TO PLACE THE LEAD THE PHYSICIAN WAS CONCERNED THEY MAY HAVE OVER-EXERCISED THE LEAD HELIX AND IT WAS DECIDED TO TRY A DIFFERENT LEAD. THE NEW LEAD WAS PLACED WITHOUT FURTHER ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS NOTED THE PATIENT HAS SARCOID, WHICH THE PHYSICIAN FEELS COULD CONTRIBUTE TO THE DIFFICULTY IN FINDING A SUITABLE LOCATION FOR LEAD PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465247 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR