BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3861418 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07259
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    February 18, 2014
    Report Date
    April 2, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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: 5076-52 IMPLANTABLE PACING LEAD, IMPLANTED: (B)(6) 2004. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) PACING LEAD WAS EXHIBITING LOW PACING LEVELS DURING A DEVICE CHECK. THE PATIENT REPORTED SHORTNESS OF BREATH AND A LACK OF ENERGY DURING THE VISIT. THE IMPLANTABLE PULSE GENERATOR (IPG) DEVICE AND LEAD SYSTEM WAS EXPLANTED 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
    337367 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Hospitalization| R E1DR01 IMPLANTABLE PULSE GENERATOR