BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2790630 · Received October 15, 2012

    Report

    Report Number
    2182208-2012-03309
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    July 1, 2012
    Report Date
    August 17, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE, AND NO USER FACILITY FOLLOW-UP IS POSSIBLE WITHOUT PRODUCT IDENTIFICATION. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. WITHOUT A SERIAL NUMBER AT THIS TIME THERE IS NO WAY TO KNOW IF THIS INFORMATION HAS BEEN REPORTED ON ANOTHER MEDWATCH REPORT. KONDOH H, FUNATSU T, TANIGUCHI K. LATE LEFT VENTRICULAR PERFORATION BY ACTIVE FIXATION PACEMAKER LEAD IMPLANTED IN THE RIGHT VENTRICULAR SEPTUM. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING A RIGHT VENTRICULAR PACING LEAD. THERE WAS ONE PATIENT IN THE ARTICLE. THE PATIENT WAS HOSPITALIZED THREE MONTHS AFTER IMPLANT OF THE LEAD DUE TO ACUTE AND SEVERE CHEST PAIN. THE LEAD HAD MIGRATED FROM ITS ORIGINAL POSITION AND PERFORATED THE OUTSIDE OF THE PERICARDIUM THROUGH THE VENTRICULAR WALL NEAR THE INTRAVENTRICULAR GROOVE. THE LEAD WAS REMOVED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC, INC. 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| L| R