BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3990044 · Received August 7, 2014

    Report

    Report Number
    2649622-2014-08856
    Event Type
    Injury
    Date Received
    August 7, 2014
    Date of Event
    May 30, 2014
    Report Date
    June 6, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: A PARTIAL LEAD WAS RETURNED IN SEGMENTS. VISUAL ANALYSIS REVEALED THE PROXIMAL CONDUCTOR OF THE LEAD BECAME EXTRINSICALLY FRACTURED DUE TO PULLING/STRETCHING/OVERSTRESS, THE INNER INSULATION OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO A TEAR, THE OUTER INSULATION OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO A CUT AND A TEAR, THE OUTER INSULATION OF THE LEAD BECAME EXTRINSICALLY DISTORTED DUE TO KINKING/BUCKLING AND PULLING/STRETCHING/OVERSTRESS AND THERE WAS APPARENT EXPLANT DAMAGE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: 5076-45 IMPLANTABLE PACING LEAD, IMPLANTED (B)(6) 2008. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD INSULATION HAD "SNOW PLOWED" DISTALLY DURING EXPLANT. INSPECTION OF THE LEAD SHOWED A PORTION OF THE RV LEAD WAS WITHOUT OUTER INSULATION. THE RV LEAD WAS SUCCESSFULLY EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462567 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Hospitalization| R P1501DR IPG