BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX

    MDR report key: 2813498 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-17257
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 18, 2012
    Report Date
    December 5, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY:THE FULL LEAD WAS RETURNED AND ANALYZED. THE HELIX WAS BENT. IT WAS VISUALLY NOTED THAT THERE WAS DAMAGE AT IMPLANT.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT ATTEMPT, THE PHYSICIAN CHECKED THE LEAD BEFORE IMPLANTING AND THE HELIX ON THE LEAD WOULD NOT DEPLOY. THE LEAD WAS NOT USED AND WAS REPLACED. 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 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5568

    Patients

    Seq Age Sex Outcome Treatment
    1 Other