BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3813052 · Received May 15, 2014

    Report

    Report Number
    2649622-2014-04832
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 23, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. PRODUCTS: 5076-45 LEAD IMPLANTED: 2002 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH THRESHOLDS, LOW PACING IMPEDANCE, OVERSENSING AND HIGH RATE EPISODES RECORDED THAT APPEAR TO BE NOISE. IT WAS FURTHER REPORTED THERE WAS LOSS OF CAPTURE AT MAX OUTPUT IN THE BIPOLAR CONFIGURATION BUT THE LEAD WAS ABLE TO CAPTURE IN UNIPOLAR. THE RIGHT ATRIAL (RA) LEAD IS REPORTED TO HAVE HIGH THRESHOLDS, OVERSENSING AND HIGH RATE EPISODES RECORDED THAT APPEAR TO BE NOISE. THE PATIENT FURTHER REPORTED FEELING POCKET STIMULATION. THE RV LEAD WAS CAPPED AND THE RA LEAD WAS REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291243 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-35

    Patients

    Seq Age Sex Outcome Treatment
    1 00018 YR Hospitalization| R ADDRL1 IPG