BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2951722 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00192
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 5, 2012
    Report Date
    November 5, 2012
    Manufacturer
    MPRI
    Product Code
    NVM
    PMA / PMN Number
    P090013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE LEAD WAS CONTINUALLY FOLDING OVER ITSELF (DUE TO DIFFICULT ANATOMY) WHILE THE PHYSICIAN WAS TRYING TO PLACE THE LEAD. THE PHYSICIAN DECIDED TO RE-STICK AND WAS ABLE TO GET THE LEAD INTO THE VENTRICLE. AFTER TESTING THE LEAD THROUGH THE ANALYZER, THERE WAS NO SENSING, IMPEDANCE VALUES WERE LOW AND THERE WAS NO OUTPUT. THE INITIAL MANIPULATION MAY HAVE DAMAGED THE LEAD. THE LEAD WAS NOT USED AND A NEW LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56571 CAPSUREFIX NOVUS MRI CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL, DUAL-BALLOON NVM MPRI 5086MRI52

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR