BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2954614 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-02385
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    October 31, 2012
    Report Date
    December 28, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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 PRODUCT: 4076 IMPLANTABLE PACING LEAD 2012 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ADDITIONAL INFORMATION WAS LATER OBTAINED FROM THE PATIENT'S CLINIC INDICATING THAT THE DEVICE AND LEADS WERE REMOVED DUE TO INFECTION AND THAT THERE WERE NO KNOWN DEVICE OR LEAD PROBLEMS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THE PATIENT'S DEVICE WAS "DEFECTIVE". THE PATIENT ALSO STATED THEY MAY HAVE HAD "BAD WIRES". T HE DEVICE AND LEADS WERE EXPLANTED AND NOT REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58082 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407645

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR