BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3990257 · Received August 7, 2014

    Report

    Report Number
    2649622-2014-08732
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    June 15, 2014
    Report Date
    June 22, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 THE INNER INSULATION OF THE LEAD BECAME EXTRINSICALLY DISTORTED DUE TO KINKING/BUCKLING. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED STRETCHING. THE ANALYST COMMENTED THAT THE LEAD WAS RETURNED STRETCHED, WITH BUCKLING OF THE INNER INSULATION. A STRETCHED LEAD MAY NOT FULLY TRANSFER TORQUE TO THE HELIX WHEN TURNING THE IS-1 CONNECTOR PIN.

    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 LEAD HELIX COULD NOT ADVANCE. THE PHYSICIAN IMPLANTED A NEW LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464221 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR