BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2131558 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10513
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    February 3, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE AND LEADS GOT INFECTED TWO MONTHS AFTER IMPLANT. FOLLOW-UP IS IN PROGRESS TO INVESTIGATE WHETHER THE IMPLANTS WERE REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE DEVICE WAS REMOVED FROM THE PATIENT DUE TO INFECTION, RESTERILIZED WITH ETO AND REIMPLANTED INTO THE PATIENT. THE LEADS REMAINED IN THE PATIENT AND NO INTERVENTION WAS PERFORMED ON THE LEADS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE AND LEADS GOT INFECTED TWO MONTHS AFTER IMPLANT. FOLLOW-UP IS IN PROGRESS TO INVESTIGATE WHETHER THE IMPLANTS WERE REMOVED AND REPLACED. 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 75 YR Hospitalization| R