BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 3860729 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-05317
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 4, 2014
    Report Date
    March 4, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. PRODUCT ID 6944-58 IMPLANTABLE TACHY LEAD IMPLANTED: 2011 (B)(6). (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEAD INTEGRITY ALERT (LIA) WAS TRIGGERED DUE TO OVERSENSING NOISE ON THE RIGHT VENTRICULAR (RV) LEAD. THE LEAD WAS CAPPED AND REPLACED. AFTER THE FELLOW USED ELECTROCAUTERY NEAR LEAD PIN DURING REPLACEMENT OF RV LEAD, THE RIGHT ATRIAL (RA) LEAD EXHIBITED LOW SENSING AND HIGH THRESHOLD. THE RA 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
    337281 CAPSURE SP NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4592-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Hospitalization| R D314DRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR