BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2121774 · Received June 13, 2011

    Report

    Report Number
    2649622-2011-07822
    Event Type
    Injury
    Date Received
    June 13, 2011
    Report Date
    March 11, 2024
    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
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. ANALYSIS OF THE LEAD IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CLINICIAN HAD CONCERNS ABOUT THE LEAD'S HIGH AND VARYING IMPEDANCES. THE LEAD WILL BE INVESTIGATED FURTHER DURING PATIENT'S GENERATOR CHANGE OUT. IT WAS ADDITIONALLY REPORTED THAT THE RIGHT ATRIAL LEAD FRACTURED. THE ATRIAL LEAD WAS CAPPED AND REPLACED. HOWEVER, DURING THE REPLACEMENT PROCEDURE THE NEW LEAD WAS UNABLE TO PASS THROUGH DUE TO THE PATIENT'S ANATOMY AND WAS NOT IMPLANTED. ANOTHER LEAD WAS IMPLANTED INSTEAD. 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 74 YR Male Hospitalization| R 6932 IMPLANTABLE TACHY LEAD| 7274 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6932 IMPLANTABLE TACHY LEAD| 7274 IMPLANTABLE PACEMAKER/CARDIO/DEFIB