BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 3991074 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08318
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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: 4024-52 LEAD 1999-(B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DEVICE FOLLOW-UP, ACCORDING TO THE LEAD ALERT TREND DATA, THE RIGHT ATRIAL (RA) LEAD SHOWED THERE WAS A LEAD POLARITY SWITCH SEVERAL YEARS AGO AND THE TREND SHOWS OVER 121,000 VALUES OF HIGH IMPEDANCE, AND APPROXIMATELY 12, 000 VALUES OF LOW IMPEDANCE. THE LEAD WAS REPROGRAMMED UNIPOLAR AND ATTEMPTED TO GO UNIPOLAR SENSING HOWEVER, THERE WAS OVERSENSING WITH MOVEMENT. THE PHYSICIAN DECIDED TO LEAVE THE PATIENT IN BIPOLAR SENSING. THE PATIENT WAS SENT TO HAVE A CHEST X-RAY AND WILL BE SEEN IN THE CLINIC IN ONE MONTH. 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
    468209 CAPSUREFIX DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 4068-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Hospitalization| R ADDR01 IPG