BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 4160947 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11693
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 1, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO HOSPITAL DUE TO BRADYCARDIA, DIZZINESS, AND LIGHTHEADEDNESS, AND WAS TAKEN TO CARDIAC CATH LAB THE NEXT DAY. THE RIGHT ATRIAL (RA) LEAD EXHIBITED NON CAPTURE, HIGH IMPEDANCE, AND NO ATRIAL SENSING. A FRACTURE WAS CONFIRMED AND THERE WAS INSULATION DAMAGE. IT WAS NOTED UNDER FLURO THAT THE TIP OF THE LEAD WAS SEPARATING FROM THE SCREW AND THE SCREW APPEARED ELONGATED. DURING TESTING, NOISE WAS SEEN. THE LEAD WAS CAPPED AND 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
    641063 CAPSUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5068

    Patients

    Seq Age Sex Outcome Treatment
    1 00023 YR Hospitalization| R ADSR01 IPG