BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2203461 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11702
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    May 12, 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 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: (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND PRIMARY ANALYSIS REVEALED ANOMALIES FOUND. THE PROXIMAL CONDUCTOR WAS DISTORTED AND BLOOD WAS PRESENT IN/ON THE HELIX/LOBE MECHANISM. THERE WAS ALSO APPARENT EXPLANT DAMAGE. (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND PRIMARY ANALYSIS REVEALED NO ANOMALIES. BLOOD WAS PRESENT IN/ON THE HELIX/LOBE MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS DISLODGMENT OF THE ATRIAL LEAD AND HIGH THRESHOLD ON THE VENTRICULAR LEAD. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED PHRENIC NERVE STIMULATION. THE LEADS WERE EXTRACTED AND REPLACED. NO PATIENT COMPLICATIONS WERE 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R