BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2612233 · Received June 11, 2012

    Report

    Report Number
    2649622-2012-07914
    Event Type
    Injury
    Date Received
    June 11, 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. EVALUATION SUMMARY: (B)(4) NO ANOMALIES FOUND, FULL LEAD ANALYZED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING THIS LEAD. IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD NEEDED TO BE REPOSITIONED, AND SUBSEQUENTLY WAS REPLACED DUE TO SENSING DIFFICULTY AND UNACCEPTABLE THRESHOLDS. 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| R (B)(4) IMPLANTABLE PULSE GENERATOR| (B)(4) IMPLANTABLE PACING LEAD