BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2811652 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-15877
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS HOSPITALIZED FOR A BOWEL OBSTRUCTION AND BECAME TACHYCARDIC. SINUS TACHYCARDIA WAS DETECTED AND THERAPY WAS WITHHELD UNTIL THE CRITERIA COULD NO LONGER BE MET. THE PATIENT RECEIVED MULTIPLE SHOCKS WITHIN A FEW MINUTES. IT WAS DETERMINED THERE WAS INTERMITTENT SENSING ON THE ATRIAL LEAD WHICH CAUSED THE INAPPROPRIATE DIAGNOSIS OF THE ARRHYTHMIA. NO FURTHER INAPPROPRIATE THERAPY WAS DELIVERED. UPON INTERROGATION OF THE DEVICE IT WAS NOTED THE P WAVE MEASUREMENT WAS LOW. THE SENSITIVITY WAS REPROGRAMMED. THE PATIENT'S BETA BLOCK WAS REINSTATED TO SLOW THE HEART RATE. THE LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN 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 PUERTO RICO, INC. 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Life Threatening| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB