BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3152761 · Received June 8, 2013

    Report

    Report Number
    3008973940-2013-00061
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 2013
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD WAS ATTEMPTED, NOT IMPLANTED DUE TO THE VESSEL "MEANDERING." THE LEAD WAS ATTEMPTED SEVERAL TIMES. A PERFORATION OF THE SUPERIOR VENA CAVA (SVC) WAS SUSPECTED. THE LEAD WAS NOT USED, ONLY AN RIGHT VENTRICULAR (RV) LEAD WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257463 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC SINGAPORE OPERATIONS 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Life Threatening