BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 1992500 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02884
    Event Type
    Injury
    Date Received
    February 15, 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
    MS, US
    Reporter Occupation
    PATIENT

    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

    THE PATIENT REPORTED THAT THE DEFIBRILLATOR AND ATRIAL LEAD WERE PUT IN THE WRONG PLACE ON THE TOP OF THE HEART AND WERE "IMPROPERLY INSTALLED." WHICH CAUSED THE PATIENT'S HEART TO "RESPOND BACKWARDS." THE PATIENT INDICATED THAT THE PROBLEM EXISTED SINCE IMPLANT AND CAUSED THE PATIENT TO "PASS OUT AND HAVE HEART PAINS." IT WAS ADDITIONALLY REPORTED THAT THE ATRIAL LEAD WAS NOT CAPTURING AND THE DEVICE HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). THE ATRIAL LEAD WAS CAPPED AND REPLACED. THE DEFIBRILLATOR WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE 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 58 YR Hospitalization| R 6944 IMPLANTABLE TACHY LEAD