BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2951807 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00246
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY # (B)(4) - THE LEAD WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THAT THE HELIX WAS DISTORTED/BENT. THE OUTER INSULATION WAS BREACHED CUT. THERE WAS APPARENT IMPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, WHEN THE PHYSICIAN WAS ATTEMPTING TO RETRACT THE HELIX BACK FROM THE ENDOCARDIUM, THE TIP OF THE LEAD BENT AND COULD NOT BE RETRACTED BACK INTO THE LEAD. THE LEAD WAS NOT USED AND A NEW 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
    56177 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4076

    Patients

    Seq Age Sex Outcome Treatment
    1