BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3152556 · Received June 7, 2013

    Report

    Report Number
    3008973940-2013-00081
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    April 6, 2013
    Report Date
    October 11, 2013
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE HELIX FUNCTIONED WITHOUT ANOMALY AND WAS NOT BENT.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRE-OPERATIVE THE LEAD'S HELIX DID NOT WORK. IT WAS NOTED THAT IT REQUIRED TWENTY-EIGHT TURNS CLOCKWISE FOR THE HELIX TO COME OUT AND THEN IT WAS NOT STRAIGHT. THE LEAD WAS NOT USED AND A NEW LEAD WAS IMPLANTED INSTEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252112 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC SINGAPORE OPERATIONS 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1