BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3863243 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-06605
    Event Type
    Injury
    Date Received
    June 10, 2014
    Report Date
    April 10, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 PRODUCTS: 5071-53 LEAD (B)(6) 2005; DTBA1D1 ICD (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH BLISTERING AS WELL AS OPENING OF THEIR INCISION WITH DRAINAGE OF PUS THREE MONTHS POST DEVICE EXCHANGE. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) SHOWED STRANDING ON THE LEADS CONCERNING FOR INFECTION. THE IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) AND LEADS WERE EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339203 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Hospitalization| R 694965 LEAD