BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2951410 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00090
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 7, 2012
    Report Date
    November 7, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. PRODUCT EVENT SUMMARY: (B)(4): THE FULL LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. THE HELIX WAS DISTORTED (PULLED/STRETCHED), AND THE LEAD APPEARED TO HAVE BEEN DAMAGED AT IMPLANT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO THE IMPLANT PROCEDURE, THE PHYSICIAN TESTED THE HELIX OF THE LEAD, AND HAD DIFFICULTY IN ADVANCING AND RETRACTING THE HELIX. THE PHYSICIAN ATTEMPTED TO TEST ANOTHER LEAD, BUT HAD SIMILAR PROBLEMS. THE LEADS WERE NOT USED, AND ANOTHER 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
    55539 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1