BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 3151848 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-05608
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 25, 2013
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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). PRODUCT: 694758 IMPLANTABLE TACHY LEAD, IMPLANTED:(B)(6) 2011; D274TRK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), IMPLANTED: (B)(6) 2011; 419578 IMPLANTABLE PACING LEAD, IMPLANTED: (B)(6) 2011.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252624 CAPSUREFIX DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 4068

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Hospitalization| R