BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2813537 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16770
    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
    TN, 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 THAT APPROXIMATELY TWO WEEKS POST IMPLANT, THE RIGHT VENTRICULAR [RV] LEAD HAD DIMINISHING R WAVES AND INCREASED THRESHOLD. THE THRESHOLD CONTINUED TO RISE DURING THE FIVE YEARS THAT THE LEAD WAS IMPLANTED. ADDITIONALLY, DURING A SCHEDULED DEVICE CHANGE-OUT PROCEDURE, THE R WAVES MEASURED LOW, THE RV LEAD THRESHOLD MEASURED HIGH AND FLUOROSCOPY REVEALED THAT THE LEAD HAD DISLODGED FROM ITS ORIGINAL POSITION. THE RV LEAD WAS CAPPED AND REPLACED. 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 84 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| P1501DR IMPLANTABLE PULSE GENERATOR