BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2124023 · Received June 14, 2011

    Report

    Report Number
    2649622-2011-08219
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    March 4, 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
    CO
    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. EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT ATTEMPT PRIOR TO IMPLANTING THE LEAD WITHIN THE BODY, IT TOOK A CERTAIN NUMBER OF TURNS TO EXTEND AND RETRACT THE HELIX. THE LEAD WAS POSITIONED AND NEEDED TO BE REPOSITIONED, BUT THE HELIX WOULD NOT FULLY RETRACT. ADDITIONALLY, THE LEAD TOOK MORE TURNS TO EXTEND AND RETRACT THE HELIX, SO THE LEAD WAS EXPLANTED AND SUCCESSFULLY REPLACED WITH ANOTHER 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 53 YR Other