BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2791603 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-15451
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    August 29, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 DURING A SCHEDULED DEVICE AND (PROPHYLACTIC) RIGHT VENTRICULAR [RV] LEAD CHANGE OUT, THE ATRIAL LEAD DISLODGED. THE PHYSICIAN ATTEMPTED TO ADVANCE THE ATRIAL LEAD BUT WAS UNABLE; THUS, THE PHYSICIAN CHOSE TO REMOVE THE LEAD. AS THE PATIENT DOES NOT HAVE A PACING INDICATION FOR AN ATRIAL LEAD, THE PHYSICIAN OPTED NOT TO REPLACE IT. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R 6949 IMPLANTABLE TACHY LEAD| 7299 IMPLANTABLE PACEMAKER/CARDIO/DEFIB