BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2203720 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11730
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    May 25, 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 Location
    NE, 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 THE ATRIAL LEAD HAD DISPLACED/FALLEN INTO THE RIGHT VENTRICLE. THE PHYSICIAN ATTEMPTED TO REPOSITION THE LEAD BACK INTO THE RIGHT ATRIUM MULTIPLE TIMES, BUT THE LEAD CONTINUED TO FALL OUT. THE LEAD WAS REMOVED AND UPON INSPECTION THE DISTAL TIP/HELIX HAD TOO MUCH TISSUE ATTACHED TO IT TO BE RE-USED. A NEW LEAD WAS THEN PLACED INTO THE RIGHT ATRIUM. 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. 4076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR| 4076 IMPLANTABLE PACING LEAD