BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3071663 · Received April 22, 2013

    Report

    Report Number
    2649622-2013-05247
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    January 28, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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: P1501DR IMPLANTABLE PULSE GENERATOR (B)(6) 2009; IMPLANTABLE PACING LEAD (B)(6) 2009. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A DEFLECTION ON THE VENTRICULAR CHANNEL OF THE VENTRICULAR ELECTROGRAM (EGM). IT WAS SUSPECTED THAT THE RIGHT VENTRICULAR LEAD WAS UNDERSENSING A PREMATURE VENTRICULAR CONTRACTION (PVC). THE 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
    171800 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00092 YR