BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 3278401 · Received August 10, 2013

    Report

    Report Number
    2649622-2013-10729
    Event Type
    Injury
    Date Received
    August 10, 2013
    Report Date
    May 13, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, 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. CONCOMITANT PRODUCTS: 419378 IMPLANTABLE PACING LEAD, (B)(6) 2005; M7700-31 MECHANICAL HEART VALVE, (B)(6) 1990. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RING ELECTRODE WAS NON-FUNCTIONAL. FOLLOW-UP HAS BEEN INITIATED TO CLARIFY THE NATURE OF ANY PERFORMANCE ISSUES. IF ANY ADDITIONAL PERFORMANCE INFORMATION IS RECEIVED, IT WILL BE SUBMITTED VIA A SUPPLEMENTAL REPORT. THE 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
    382232 CAPSUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5068

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 8042 IMPLANTABLE CRT-P