BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3990256 · Received August 7, 2014

    Report

    Report Number
    3008973940-2014-00287
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 2014
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND THE DISTAL CONDUCTOR OF THE LEAD BECAME EXTRINSICALLY DISTORTED DUE TO PULLING/STRETCHING/OVERSTRESS. IT WAS NOTED THAT VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT AND VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED STRETCHING. LEAD RETURNED DAMAGED, EXTRINSIC/PULLED/ STRETCHED/ OVERSTRESS.

    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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PHYSICIAN FOUND IT DIFFICULT TO PEEL AWAY THE INTRODUCER, DAMAGING THE LEAD. THE LEAD WAS 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
    463716 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC SINGAPORE OPERATIONS 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1