BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 3152669 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-06728
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 23, 2013
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT MEDICAL PRODUCTS: A3DR01 IMPLANTABLE PULSE GENERATOR: (B)(6) 2013. 5086MRI52 IMPLANTABLE PACING LEAD: (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH CHEST PAIN. THE RIGHT VENTRICULAR (RV) LEAD HAD LOW R-WAVES, HIGH THRESHOLD, AND NO CAPTURE IN BIPOLAR OR UNIPOLAR CONFIGURATION. A THORACOTOMY WAS CONDUCTED AND A PERFORATION SITE WAS OBSERVED. THE LEAD WAS EXPLANTED AND WAS REPLACED WITH A NEW LEAD. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253197 CAPSUREFIX NOVUS MRI DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI58

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R