BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3992125 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-10045
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 27, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: PERFORMANCE DATA OF THE LEAD WAS COLLECTED FROM THE DEVICE AND ANALYSIS OF THE DEVICE MEMORY YIELDED NO ANOMALIES.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (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 AND ANALYZED. THE OUTER INSULATION OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO A CUT. BLOOD WAS OBSERVED ON THE SLEEVE-HEAD OF THE LEAD. THE OUTER INSULATION OF THE LEAD WAS OBSERVED TO HAVE BLOOD INGRESSION IN THE LUMEN. VISUAL ANALYSIS INDICATES THE LEAD WAS DAMAGED AT IMPLANT. IT WAS NOTED THAT THE LEAD WAS RECEIVED WITH THE HELIX FULLY EXTENDED WITH DRIED BLOOD ON SLEEVE-HEAD. THE AMOUNT OF BLOOD INGRESSION ALONG THE LEAD LENGTH LEADS TO THE CONCLUSION THAT THE CUT OCCURRED AT IMPLANT. THE OUTER INSULATION BREACH DID CONTRIBUTE TO THE COMPLAINT OF HIGH THRESHOLDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST IMPLANT INTERROGATION SHOWS HIGH THRESHOLDS ON THE RIGHT VENTRICULAR (RV) LEAD. A CHEST FLUOROSCOPY SHOWS A POSSIBLE MICRO-DISLODGEMENT ON THE LEAD. THE RV LEAD WAS REVISED AND PLACED IN THE LOW SEPTAL REGION INSTEAD OF THE RV APEX. AFTER THE LEAD REVISION, ANOTHER POST OP INTERROGATION SHOWS HIGH THRESHOLDS ON THE RV LEAD AGAIN. THE RV LEAD WAS EXTRACTED AND A NEW LEAD WAS IMPLANTED. IT WAS FURTHER REPORTED THAT THE RIGHT ATRIAL (RA) LEAD WAS FOUND TO HAVE DISLODGED AFTER THE FIRST RV LEAD REVISION. THE RA LEAD WAS EXTRACTED AND A NEW LEAD WAS IMPLANTED. THE PATIENT HAD A PLEURAL EFFUSION DUE TO THE LEAD REPLACEMENT AND WAS TREATED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469635 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Hospitalization| L| R 5076-52 LEAD, VEDR01 IPG