BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3992313 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09935
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    March 26, 2014
    Report Date
    June 13, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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 MEDICAL PRODUCTS: P1501DR, IMPLANTABLE PACING LEAD, (B)(6) 2006. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD HAD NOISE. THE RA LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS LATER REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) HAD A MIRRORED IMAGE ISSUE AND IT INVOLVED THE RING CONDUCTORS ON BOTH LEADS MAKING CONTACT. IT WAS ALSO NOTED THAT THE RA LEAD HAD AN INSULATION BREACH. THE IPG WAS PREVIOUSLY EXPLANTED AND REPLACED AND THE RIGHT VENTRICULAR (RV) LEAD REMAINS IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472040 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD