BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 1874670 · Received October 19, 2010

    Report

    Report Number
    2649622-2010-11495
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S38
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 THERE WAS A CONCERN THAT HIGH IMPEDANCE LEADS' VARIATIONS BETWEEN UNIPOLAR AND BIPLOAR IMPEDANCE MEASUREMENTS, WHICH MAY BE LARGER THAN OUR CUSTOMERS ARE USED TO, COULD LEAD TO FALSE INDICATIONS OF LEAD ISSUES AND POTENTIAL LEAD REPLACEMENTS THAT ARE UNNECESSARY. NO LEADS ARE KNOWN TO HAVE BEEN REMOVED FROM SERVICE AS A RESULT OF THIS EVENT. 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. 5054 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other 5554 IMPLANTABLE PACING LEAD| 7088B IMPLANTABLE PULSE GENERATOR