BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2812542 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16686
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    September 27, 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
    MA, US
    Reporter Occupation
    HEALTH 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ALERT TRIGGERED. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD AND THE RIGHT VENTRICULAR (RV) LEAD WERE OUT OF RANGE ON THE DAY OF IMPLANT. THE DEVICE WAS CHECKED AGAIN FOUR DAYS POST IMPLANT AND THE RA LEAD AND THE RV LEAD PACE/SENSE IMPEDANCE MEASUREMENTS WERE WITHIN RANGE, HOWEVER, THE RV LEAD HIGH VOLTAGE AND SVC PORTIONS STILL HAD HIGH IMPEDANCE. IT WAS ALSO REPORTED THAT THE RV LEAD CONNECTION WITH THE IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) HAD BECOME LOOSE AND THAT THE PHYSICIAN HAS SOME DIFFICULTY SETTING THE RV LEAD PIN DURING IMPLANT. THE RV LEAD WAS REDEPLOYED AND THE CONNECTION WITH THE ICD WAS RESET. THE RV IMPEDANCE IS NOW WITHIN NORMAL LIMITS AND THE RV LEAD, RA LEAD AND ICD REMAIN IN USE. NO 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 83 YR Hospitalization| R