BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3991010 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08352
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 26, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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. PRODUCTS: 5076-58 LEAD, IMPLANTED: 2014 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHEST PAIN TWO DAYS POST IMPLANT. THERE WAS LOSS OF RIGHT VENTRICULAR (RV) LEAD CAPTURE WITH AN APPROXIMATE FIVE SECOND PAUSE. AN ECHOCARDIOGRAM SHOWED PERICARDIAL EFFUSION. BOTH THE RV AND ATRIAL LEADS HAD APPARENTLY DISLODGED. THE PHYSICIAN OPTED TO REPOSITION BOTH THE RV AND THE ATRIAL LEADS DUE TO BEING UNSURE WHAT LEAD CAUSED THE EFFUSION. BOTH LEADS REMAIN 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
    471698 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Hospitalization| L| R ADDRL1 IPG