BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3993687 · Received August 8, 2014

    Report

    Report Number
    3008973940-2014-00303
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 23, 2014
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 HELIX OF THE LEAD BECAME EXTRINSICALLY DISTORTED DUE TO PULLING/ STRETCHING/OVERSTRESS. THE HELIX OF THE LEAD WAS EXTRINSICALLY BENT. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT.

    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 THE DURING ATTEMPT TO IMPLANT THE RIGHT VENTRICULAR (RV) LEAD THERE WERE PROBLEMS CROSSING THE RIGHT VENTRICULAR AND IT WAS NOTED THAT THE LEAD WAS HOOKED. THE RV LEAD WAS WITHDRAWN AND EXCHANGED FOR A DIFFERENT LEAD. UPON WITHDRAWAL OF THE RV LEAD IT WAS NOTED THAT THE TIP WAS PARTIALLY EXTRACTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472134 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC SINGAPORE OPERATIONS 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1