BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2606001 · Received June 8, 2012

    Report

    Report Number
    2649622-2012-05648
    Event Type
    Injury
    Date Received
    June 8, 2012
    Date of Event
    January 1, 2012
    Report Date
    March 1, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. REFERENCED ARTICLE: "CLINICAL ROUTINE IMPLANTATION OF A DUAL CHAMBER PACEMAKER SYSTEM DESIGNED FOR SAFE USE WITH MRI." HERZSCHRITTMACHERTHER. ELEKTROPHYSIOL. 2011;22(4):233-242.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING THESE LEADS. IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD EXIT BLOCK/DISLODGEMENT AND NEEDED TO BE REPOSITIONED. FURTHER INVESTIGATION INDICATED THAT THERE IS NO DESIGNATION FOR WHICH LEAD IS THE RV LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS MRI IMPLANTABLE PACING LEAD NVN MEDTRONIC PUERTO RICO, INC. 5086MRI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R (B)(4) IMPLANTABLE PULSE GENERATOR