BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2052961 · Received April 13, 2011

    Report

    Report Number
    2649622-2011-05723
    Event Type
    Injury
    Date Received
    April 13, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 THE LEFT VENTRICLE (LV) LEAD WILL NOT CAPTURE WHEN IT IS PROGRAMMED TO LEFT VENTRICLE TIP TO RIGHT VENTRICLE RING AND THE LEAD IMPEDANCE IS UNDEFINED. IT WAS FURTHER REPORTED THAT WHEN THE LV LEAD IS PROGRAMMED TO UNIPOLAR IT IS ABLE TO CAPTURE. POSSIBLE ISSUE WITH EITHER THE LV LEAD OR THE RIGHT VENTRICLE (RV) LEAD AS THEY ARE SHARING THE RIGHT VENTRICLE RING. BOTH LEADS ARE STILL 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| 8042 IMPLANTABLE PULSE GENERATOR