BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 2202180 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11289
    Event Type
    Injury
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S38
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 THERE WAS A ATRIAL LEAD WARNING AND THE POLARIZATION HAD CHANGED FROM BIPOLAR TO UNIPOLAR. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR HAD BEEN PROGRAMMED BIPOLAR WHERE IT HAD PREVIOUSLY BEEN UNIPOLAR. THERE WERE TWO VENTRICULAR EPISODES WITH NOISE DUE TO OVERSENSING AND THE LEAD HAD LOSS OF CAPTURE AT HIGHER OUTPUTS WHILE PROGRAMMED BIPOLAR. THE ATRIAL LEAD WAS RETURNED TO BIPOLAR SETTING AND HAS HAD STABLE MEASUREMENT FOR TWO FOLLOW-UPS. THE VENTRICULAR LEAD WAS PROGRAMMED UNIPOLAR. THE 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 CAPSURE Z NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5554 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention (B)(4) IMPLANTABLE PULSE GENERATOR