BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 2813274 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16511
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S38
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 THE REMOTE TRANSMISSION SHOWED THERE WAS ATRIAL LEAD WARNING AND POLARITY SWITCH. IT WAS NOTED THAT THIS OCCURRED ON THE SAME DAY AS AN IN-OFFICE INTERROGATION. IT WAS FURTHER NOTED THERE WAS OVERSENSING ATTRIBUTED TO THE LEAD BEING PROGRAMMED UNIPOLAR. THE LEAD WAS DETERMINED TO BE FUNCTIONING NORMALLY AND THE POLARITY WAS CHANGED BACK TO BIPOLAR. THE LEAD REMAINS 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 CAPSURE Z NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5554

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention 5054 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR