BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2952180 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00424
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 14, 2012
    Report Date
    November 14, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. ANALYSIS FOUND THE GUIDE TOOTH WAS DAMAGED. BLOOD WAS NOTED ON THE DISTAL ELECTRODE AND PROXIMAL CONDUCTOR. THE OUTER INSULATION WAS BREACH CUT AND THE INNER INSULATION WAS KINKED/BUCKLED. THE LEAD WAS STRETCHED AND IMPLANT DAMAGE WAS NOTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANTING PROCEDURE, THE HELIX MECHANISM WAS DEFECTIVE. THE HELIX WAS SCREWED OUT IN THE PACKAGE AND IT WAS NOT POSSIBLE TO SCREW IT IN FOR IMPLANT. THE LEAD WAS OPENED AND NOT USED. ANOTHER LEAD WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56464 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR