BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2813441 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16527
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    August 21, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 FULL LEAD WAS RETURNED AND ANALYZED. THE DISTAL CONDUCTOR WAS DISTORTED AND FRACTURED (OVERSTRESS). THE OUTER INSULATION WAS BREACHED CUT. THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM. VISUAL ANALYSIS NOTED THE LEAD WAS DAMAGED AT IMPLANT. THE LEAD WAS RECEIVED WITH THE DISTAL CONDUCTOR DISTORTED AND FRACTURED WITHIN THE CONNECTOR. THE DISTAL CONDUCTOR HAS BEEN FRACTURED WITH THE CONNECTOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE SCREW WOULD NOT DEPLOY FROM THE LEAD. THE LEAD WAS REMOVED AND WAS REPLACED WITH A NEW 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 81 YR Other