BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3994093 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08983
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 17, 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. CONCOMITANT PRODUCTS: 694965 IMPLANTABLE TACHY LEAD (B)(6) 2005; 419488 IMPLANTABLE PACING LEAD (B)(6) 2005; 5076-52 IMPLANTABLE PACING LEAD (B)(6) 2005. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEW DAYS AFTER A ROUTINE GENERATOR CHANGE, A LEAD WARNING TRIGGERED FOR HIGH PACING IMPEDANCE ON THE RIGHT VENTRICULAR (RV) LEAD. A FRACTURE WAS SUSPECTED. THE PACE/SENSE PORTION OF THE RV LEAD WAS CAPPED AND A NEW PACE/SENSE LEAD WAS IMPLANTED. THE HIGH VOLTAGE PORTION OF THE RV LEAD REMAINS IN USE. THE FOLLOWING DAY, ANOTHER LEAD WARNING TRIGGERED FOR HIGH PACING IMPEDANCE ON THE PACE/SENSE RV LEAD. AN X-RAY OF THE DEVICE HEADER REVEALED THAT THE PACE/SENSE RV PIN WAS NOT FULLY SEATED IN THE BLOCK. THE PHYSICIAN SUSPECTED A HEADER ISSUE OR DEBRIS IN THE RV PORT. THE DEVICE WAS EXPLANTED AND REPLACED. THE PACE/SENSE RV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467132 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Hospitalization| R DTBA1D1 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR