BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2811969 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-17143
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 12, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: (B)(4): NO ANOMALIES FOUND, HOWEVER BLOOD WAS NOTED ON THE DISTAL ELECTRODE; FULL LEAD RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT ATTEMPT, WHEN THE PHYSICIAN WAS ADVANCING THE LEAD IT WOULDN'T MOVE FORWARD AND THEN IT WAS NOTED THAT THE HELIX WAS EXTENDED ALTHOUGH HE'S NOT SURE HOW THAT HAPPENED. WHEN THE PHYSICIAN TRIED TO RETRACT IT, IT WOULDN'T. IT WAS THOUGHT THAT THERE WAS SOME CLOT OR DEBRIS IN THE LEAD BEHIND THE HELIX PREVENTING IT FROM RETRACTING. ANOTHER LEAD WAS PLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4076

    Patients

    Seq Age Sex Outcome Treatment
    1 Other