BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2131060 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10366
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    April 29, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    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 WITH NO ANOMALIES FOUND. THERE WAS BLOOD IN/ON THE HELIX MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING AN IMPLANT ATTEMPT, THE LEAD HAD HIGH IMPEDANCE AND ELEVATED THRESHOLD. THE LEAD WAS NOT USED AND ANOTHER LEAD WAS SUCCESSFULLY IMPLANTED. 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other