BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3860159 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-05527
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 3, 2014
    Report Date
    March 6, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. CONCOMITANT PRODUCT: 5076-45, LEAD, IMPLANTED: (B)(6) 2014. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND THE OUTER INSULATION OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO A CUT. THE PROXIMAL CONDUCTOR OF THE LEAD BECAME EXTRINSICALLY DISTORTED DUE TO PULLING/STRETCHING/OVERSTRESS AND WAS OBSTRUCTED WITH BLOOD. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED POCKET STIMULATION, AND THE RIGHT VENTRICULAR (RV) LEAD HAD ALERTED DUE TO LOW IMPEDANCE. A POLARITY SWITCH, SHORT INTERVAL COUNTS (SICS), AND NOISE WERE IDENTIFIED. IT WAS FURTHER REPORTED THAT THE PATIENT HAS A SUPERIOR VENA CAVA STENT IMPLANTED WHICH THE LEADS PASS THROUGH. THE PHYSICIAN BELIEVES THE ISSUE IS DUE TO LEAD ABRASION FROM THE STENT. THE RV LEAD WAS 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
    337280 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Hospitalization| R ADDR01 IPG