BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2951994 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00332
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 9, 2012
    Report Date
    November 9, 2012
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD IN THE PROXIMAL CONDUCTOR, THERE WAS BLOOD IN THE DISTAL ELECTRODE, THE HELIX WAS PULLED/STRETCHED/OVERSTRESSED, THE OUTER INSULATION WAS BREACHED CUT, AND THE LEAD APPEARED TO BE DAMAGED AT IMPLANT. THE LEAD WAS RETURNED WITH BLOOD ON THE HELIX AND THE HELIX FULLY RETRACTED. HELIX LENGTH WAS MEASURED AT THIS TIME AND WAS NOT WITHIN SPECIFICATION. HELIX WAS CLEANED IN PREPARATION FOR HELIX EXTENSION/RETRACTION AND LENGTH TESTING. EXTENSION/RETRACTION AND LENGTH TESTING WERE PERFORMED AND HELIX LENGTH WAS OUT OF SPECIFICATION. HELIX WAS LIKELY STRETCHED DURING THE ATTEMPTED IMPLANT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE ATRIAL LEAD DISLODGED MULTIPLE TIMES. IT WAS ALSO REPORTED THAT THE PHYSICIAN VISUALIZED TISSUE IN THE HELIX OF THE LEAD. THE ATRIAL LEAD WAS REMOVED AND A DIFFERENT LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55416 CAPSUREFIX NOVUS MRI DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI52

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR