BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2130995 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10336
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    April 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
    HK
    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. IT WAS ALSO NOTED THAT THERE WAS BLOOD IN/ON THE HELIX MECHANISM. (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS ALSO NOTED THAT THE PROXIMAL CONDUCTOR WAS DISTORTED, ALL CONDUCTORS WERE STRETCHED, THE INNER INSULATION WAS KINKED BUCKLED, THE INNER INSULATION WAS TORN, THERE WAS BLOOD IN/ON THE HELIX MECHANISM, THE LEAD WAS STRETCHED, AND THE LEAD WAS DAMAGED AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT ATTEMPT, THE RIGHT ATRIUM (RA) LEAD SHOWED NOISE AND WAS NOT ABLE TO SENSE OR PACE THE HEART. THE TESTING CABLES WERE CHANGED BUT THE RESULTS WERE THE SAME. THEREFORE THE RA LEAD WAS REMOVED AND SUCCESSFULLY REPLACED WITH A NEW LEAD. IT WAS ALSO REPORTED THAT THE REPLACEMENT RIGHT ATRIUM (RA) LEAD DISLODGED POST IMPLANT. DURING RA LEAD REPOSITIONING, THE HELIX EXTENSION WAS PERFORMED SEVERAL TIMES, HOWEVER THE LEAD WOULD NOT SECURE IN THE ATRIUM AND TISSUE WAS FOUND ON THE HELIX. THEREFORE THE RA LEAD WAS REMOVED AND 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R