BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3051499 · Received April 10, 2013

    Report

    Report Number
    2649622-2013-04886
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 25, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    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). CONCOMITANT PRODUCTS: 407452 IMPLANTABLE PACING LEAD, IMPLANTED: (B)(6) 2013; ADDRS1 IMPLANTABLE PULSE GENERATOR (IPG), IMPLANTED: (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THE LEADS "HAD MOVED". ADDITIONAL INFORMATION OBTAINED FROM THE CLINIC NOTED THAT THE LEADS HAD DISLODGED. THE LEADS WERE REVISED AND REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153995 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407645

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Hospitalization| R