BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2130390 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10156
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    April 15, 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 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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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 FOR (B)(4): THE FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND THE LEAD WAS STRETCHED. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED), THE INNER INSULATION WAS KINKED/BUCKLED, THE OUTER INSULATION WAS BREACHED CUT, THERE WAS BLOOD IN/ON THE HELIX MECHANISM AND THE LEAD APPEARED DAMAGED AT IMPLANT. THE ANALYST COMMENTED THAT THE LEAD HAD BEEN STRETCHED, SO THE INNER TUBING BUCKLED AND IT PREVENTS THE HELIX FROM FUNCTIONING PROPERLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT AND FOLLOWING PLACEMENT OF THE RIGHT ATRIUM (RA) LEAD WITH ACCEPTABLE MEASUREMENTS, THE DOCTOR DECIDED TO REPOSITION THE LEAD FOR BETTER ANATOMICAL PLACEMENT IN THE RA. IT WAS ALSO REPORTED THERE WERE FOUR DIFFERENT ATTEMPTS TO PLACE THE LEAD AT DIFFERENT RA LOCATION, HOWEVER THE LEAD WOULD NOT MAINTAIN POSITION AND DISLODGED WHEN REMOVING THE J-STYLET. THE RA LEAD WAS CAPPED AND REPLACED WITH A NEW LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT AND FOLLOWING PLACEMENT OF THE RIGHT ATRIUM (RA) LEAD WITH ACCEPTABLE MEASUREMENTS, THE DOCTOR DECIDED TO REPOSITION THE LEAD FOR BETTER ANATOMICAL PLACEMENT IN THE RA. IT WAS ALSO REPORTED THERE WERE FOUR DIFFERENT ATTEMPTS TO PLACE THE LEAD AT DIFFERENT RA LOCATION, HOWEVER THE LEAD WOULD NOT MAINTAIN POSITION AND DISLODGED WHEN REMOVING THE J-STYLET. THE RA LEAD WAS CAPPED 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 65 YR Other