BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3992149 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-10039
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY : THE FULL LEAD WAS RETURNED, ANALYZED, AND VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED STRETCHING. IT WAS NOTED THAT THE PROXIMAL CONDUCTOR OF THE LEAD BECAME EXTRINSICALLY DISTORTED DUE TO PULLING/STRETCHING/OVERSTRESS, THE INNER INSULATION OF THE LEAD BECAME EXTRINSICALLY DISTORTED DUE TO KINKING/BUCKLING, AND VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. THE ANALYST NOTED THAT STYLET INSERTION TEST PASSED.

    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 IMPLANT OF THE RIGHT ATRIAL (RA) LEAD THE PHYSICIAN WAS UNABLE TO GET THE STYLET DOWN THE LEAD AND THERE WAS CONCERN THE LEAD HAD GOTTEN BENT. 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
    469647 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR