BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2964960 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-01928
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 6, 2012
    Report Date
    December 10, 2012
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD WAS DISLODGED AND FREE-FLOATING IN THE RIGHT ATRIUM. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD POSITION LOOKED QUESTIONABLE ON FLUOROSCOPY. BOTH LEADS WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68215 CAPSUREFIX NOVUS MRI DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI52

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Hospitalization| R (B)(4) IMPLANTABLE CARDIAC PACEMAKER