BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 2951930 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00325
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 9, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD UNIPOLAR IMPEDANCE WAS HIGHER THAN THE BIPOLAR IMPEDANCE, THERE WERE A HIGH NUMBER OF LOW IMPEDANCE PACES AND A LEAD WARNING AND POLARITY SWITCH OCCURRED. IT WAS ALSO REPORTED THAT THE PATIENT WAS EXPERIENCING SOME POCKET STIMULATION WITH UNIPOLAR PACING, THE LEAD WAS NOT SENSING WHEN IN BIPOLAR PACING CONFIGURATION AND INSULATION FAILURE WAS SUSPECTED. THE RV LEAD WAS CAPPED 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
    56400 CAPSUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4068-58

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR