BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2124043 · Received June 14, 2011

    Report

    Report Number
    2649622-2011-08229
    Event Type
    Injury
    Date Received
    June 14, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CAME TO THE HOSPITAL WITH PAIN IN THE LEFT SHOULDER. IT WAS ALSO REPORTED THAT THE PATIENT HAD DIFFICULTY MOVING THE LEFT ARM. A THROMBOSIS OF THE LEFT SUBCLAVIAN VEIN WAS FOUND THROUGH PHLEBOGRAPHY. THE PATIENT WAS HOSPITALIZED AND MEDICATION WAS ADMINISTERED UNTIL THE SYMPTOMS WERE RESOLVED. THE LEADS ARE STILL IN USE. NO FURTHER 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. 4076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 69 Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB