BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 3050993 · Received April 10, 2013

    Report

    Report Number
    2649622-2013-04782
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    February 4, 2013
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. (B)(4). (B)(4) IMPLANTABLE PULSE GENERATOR (IPG) IMPLANTED: 2012 (B)(6); 5068-52 IMPLANTABLE PACING LEAD IMPLANTED: 2001-(B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED AN INFECTION OCCURRED. THE LEAD WAS REMOVED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151937 CAPSUREFIX DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 4068-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Hospitalization| R