BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1922543 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12996
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    September 22, 2010
    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
    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 THE ATRIAL LEAD WAS NOT CAPTURING THE HEART AT MAX OUTPUT. IMPEDANCE MEASUREMENTS FOR THE LEAD WERE STABLE WITHIN NORMAL RANGE AND THERE WAS SOME INTERMITTENT FAR FIELD R-WAVE SENSING. THE PATIENT HAD BEEN FEELING POORLY FOR ABOUT THE LAST WEEK PRIOR TO THE FOLLOW-UP IN THE CLINIC. SHE WAS RECENTLY STARTED ON SOME NEW MEDICATIONS. THE LEAD WAS REPLACED. 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 46 YR Required Intervention (B)(4) IMPLANTABLE PULSE GENERATOR| 4076 IMPLANTABLE PACING LEAD