BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 3992570 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09792
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 23, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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

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

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND THE OUTER INSULATION OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO A TEAR. THE OUTER INSULATION OF THE LEAD WAS OBSERVED TO HAVE BLOOD INGRESSION. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. THE ANALYST NOTED THAT THE LEAD WAS RETURNED WITH THE OUTER INSULATION BREACHED AND BLOOD INGRESSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATTEMPTED IMPLANT, THE PHYSICIAN EXPERIENCED DIFFICULTIES PLACING THE LEAD DUE TO THE UNUSUALLY SHAPED LEFT SUBCLAVIAN VEIN OF THE PATIENT. AN ATTEMPT TO USE THE CUT-DOWN METHOD WAS MADE BY EXPOSING THE VEIN AND INSERTING THE LEAD, HOWEVER, THE LEAD COULD NOT CROSS THE ACUTE ANGLE JUST BELOW THE CLAVICLE. THE LEAD BODY WAS INADVERTENTLY PUNCTURED DURING THE THREADING OF THE SUTURE SLEEVE IN AN ATTEMPT TO INSERT THE LONG SHEATH FROM THE SIDE OF THE LEAD THAT HAD BEEN INSERTED ALREADY. THE LEAD WAS REMOVED AND REPLACED SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472469 CAPSURE Z NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5054-58

    Patients

    Seq Age Sex Outcome Treatment
    1