BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3160363 · Received June 10, 2013

    Report

    Report Number
    2649622-2013-08004
    Event Type
    Injury
    Date Received
    June 10, 2013
    Report Date
    March 22, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    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 RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: C2TR01 IMPLANTABLE PULSE GENERATOR (IPG) (B)(6) 2012; 2188 IMPLANTABLE PACING LEAD (B)(6) 2001; 1488TC COMPETITOR IMPLANTABLE PACING LEAD (B)(6) 2001. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED SEPSIS. THE LEFT VENTRICULAR (LV) LEAD, RIGHT VENTRICULAR (RV) LEAD AND THE IMPLANTABLEPULSE GENERATOR (IPG) WERE REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259901 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Hospitalization| R