BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2810568 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16011
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    September 5, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) - THE DEVICE WAS RETURNED TO THE MANUFACTURER AND ANALYZED. NO ANOMALIES WERE FOUND. (B)(4) - THE FULL LEAD WAS RETURNED IN SEGMENTS TO THE MANUFACTURER AND ANALYZED. NO ANOMALIES WERE FOUND. THE PROXIMAL CONDUCTOR WAS STRETCHED AND DISTORTED. ALL CONDUCTORS HAD BLOOD/BODY FLUID (NOT OBSTRUCTED). THE INNER INSULATION AND INNER TUBING WERE KINKED/BUCKLED. THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND THE HELIX/LOBE WAS DISTORTED AND BENT. THE LEAD WAS STRETCHED AND HAD APPARENT EXPLANT DAMAGE. (B)(4) - THE PARTIAL LEAD WAS RETURNED IN SEGMENTS TO THE MANUFACTURER AND ANALYZED. NO ANOMALIES WERE FOUND. THE PROXIMAL CONDUCTOR WAS STRETCHED AND DISTORTED. ALL CONDUCTORS HAD BLOOD/BODY FLUID (NOT OBSTRUCTED). THE INNER INSULATION AND INNER TUBING WERE KINKED/BUCKLED. THE INNER INSULATION WAS TORN AND HAD A BREACHED CUT. THE OUTER INSULATION HAD COSMETIC AND BREACHED CUTS, AND COSMETIC DEPRESSION. THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND THE HELIX/LOBE WAS DISTORTED AND BENT. THE LEAD WAS STRETCHED AND HAD APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION. THE DEVICE AND LEADS WERE REMOVED. NO FURTHER 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 71 YR Hospitalization| R