BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2813549 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-17024
    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
    MI, US
    Reporter Occupation
    PHYSICIAN

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD SYMPTOMS OF BEING DIZZY AND LIGHTHEADED AT TIMES BUT WAS BETTER AFTER SITTING DOWN TO REST. A CHECK OF THE RIGHT VENTRICULAR (RV) LEAD FOUND THE BIPOLAR IMPEDANCE HAD INCREASED OVER THE PAST YEAR FROM THE 600 OHMS RANGE TO GREATER THAN 2000 OHMS AND THAT THE BIPOLAR THRESHOLD HAD ALSO INCREASED. THE RV LEAD SETTINGS WERE REPROGRAMMED UNTIL THE RV LEAD WAS CAPPED AND REPLACED. 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 87 YR Hospitalization| R 4592 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR