BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2122461 · Received June 13, 2011

    Report

    Report Number
    2649622-2011-07852
    Event Type
    Injury
    Date Received
    June 13, 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
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED AND ANALYSIS FOUND AN OUTER INSULATION BREACHED (CLAVICLE-RIB CRUSH), THAT ALL CONDUCTORS HAD BLOOD/BODY FLUID (NOT OBSTRUCTED), THE INNER INSULATION WAS KINKED BUCKLED, THE STYLET WAS STUCK IN LEAD-DISTAL COIL AND THAT THE LEAD WAS STRETCHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE MONTHS AFTER THE IMPLANT, DOCTORS DISCOVERED THAT THE POCKET WAS INFECTED. AFTER THE PUNCTION OF THE POCKET THEY SAW THAT THE INFECTION WAS CAUSED BY STAFILOCOCOS EPIDERMIDIS. AT THE NEXT FOLLOW UP THE LEAD THRESHOLD HAD INCREASED. THE PHYSICIAN DECIDED TO EXTRACT THE LEAD. AT EXTRACTION THE PHYSICIAN WASN'T ABLE TO EXTRACT THE HELIX BUT FINALLY WAS ABLE TO EXTRACT IT BY TURNING THE WHOLE 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R