BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2123238 · Received June 14, 2011

    Report

    Report Number
    2649622-2011-07940
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    February 27, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY FOR (B)(4): THE FULL LEAD WAS RECEIVED AND ANALYZED. THERE WERE NO ANOMALIES FOUND. ADDITIONAL FINDINGS OF THE PROXIMAL CONDUCTOR BLOOD/BODY FLUID (NOT OBSTRUCTED), AN OUTER INSULATION BREACHED CUT, AND BLOOD IN/ON HELIX MECHANISM ALONG WITH APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING IMPLANT THERE WAS A PERFORATION OF THE INTERVENTRICULAR SEPTUM. THE LEAD WAS REMOVED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE OBSERVED AS A RESULT OF THE 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R