BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 3051232 · Received April 10, 2013

    Report

    Report Number
    2649622-2013-04812
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    October 26, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: 5068 IMPLANTABLE PACING LEAD (B)(6) 1999; 5071 IMPLANTABLE PACING LEADS (2) (B)(6) 2010; 7001 IMPLANTABLE DEFIB LEAD (B)(6) 2007. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH PACING THRESHOLD MEASUREMENTS AND NO CAPTURE AT HIGH OUTPUT. THE RV LEAD WAS CAPPED AND AN INACTIVE CHRONIC LEAD WAS REACTIVATED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149456 CAPSUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5068-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Hospitalization| R (B)(4) IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR