BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE FIX

    MDR report key: 3051522 · Received April 10, 2013

    Report

    Report Number
    2649622-2013-04844
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    December 31, 2012
    Report Date
    January 2, 2013
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND LEAD INSULATION BREACH AT THE FIRST RIB/CLAVICLE WAS FOUND. IT WAS NOTED THAT THERE WAS BLOOD ON THE LEAD CONDUCTOR (NOT OBSTRUCTED) AND THE DISTAL END/ELECTRODE WAS COVERED WITH BODY TISSUE/FIBROTIC GROWTH. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HAD INCREASED THRESHOLD VALUES OVER TIME, BUT NOW SHOWED HIGH THRESHOLD VALUES. THE LEAD WAS EXPLANTED AND WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150042 CAPSURE FIX DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI58

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Hospitalization| R