BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 2953352 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-01143
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 15, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 PRODUCT: (B)(4), IMPLANTABLE PACING LEAD, (B)(6) 1999. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THERE WAS SIGNIFICANT UNDERSENSING AND NOISE WAS NOTED ON THE ATRIAL CHANNEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ATRIAL LEAD WARNING. THE LEAD HAD HIGH IMPEDANCE, HIGH THRESHOLDS, AND OVERSENSING WHICH IS CAUSING MODE SWITCHING. THE OVERSENSING INCREASED WITH ISOMETRICS. IT WAS ALSO NOTED THAT THE PACING PERCENTAGE INCREASED IN THE VENTRICLE DUE TO THE OVERSENSING. REPROGRAMMING GOT THE PATIENT VENTRICULAR SENSING AGAIN. 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
    57000 CAPSUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5068-52

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention (B)(4) IMPLANTABLE PULSE GENERATOR (IPG)