BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3863084 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-06530
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 30, 2013
    Report Date
    July 2, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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: 693565 LEAD 2013-(B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO MONTHS AFTER IMPLANT, THE PATIENT HAD A PURULENT INCISION WOUND WITH POCKET INFECTION. A TRANSESOPHAGEAL E CHOCARDIOGRAPHY (TEE) NOTED AN ¿ARM FLOATING STRUCTURE¿ IN THE RIGHT VENTRICLE. IT WAS ALSO REPORTED THAT THE PATIENT HAD A FISTULA IN THE AREA OF THE THORACOTOMY. THE IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) AND LEADS WERE REMOVED AND PATIENT PLACED ON ANTIBIOTICS. THE PATIENT IS ENROLLED IN THE (B)(6) CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340509 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407652

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Hospitalization| R D354TRG ICD