BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3991318 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08196
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 2, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS A HISTORY OF PRESYNCOPAL EPISODES WHICH WERE ATTRIBUTED TO ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. DURING THE MOST RECENT ABLATION PROCEDURE, THE RIGHT VENTRICULAR (RV) LEAD INDICATED A SUDDEN NON-CAPTURE CONDITION WITH HIGH THRESHOLDS. THE PHYSICIAN WAS ABLATING NEAR THE CORONARY SINUS AND DID NOT BELIEVE THAT THE ABLATION WAS THE CAUSE OF THE LEAD MALFUNCTION. THE PHYSICIAN BELIEVED THE LEAD ISSUE WAS LIKELY THE CAUSE OF THE PATIENT'S PRESYNCOPE. 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
    468426 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Hospitalization| R 5568-45 LEAD