BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1922806 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-13083
    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/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 DAY AFTER ICD UPGRADE THE ATRIAL LEAD IMPEDANCE AND THRESHOLDS WERE HIGH. FARFIELD OVERSENSING WAS ALSO NOTED. UPON OPENING THE POCKET AND TESTING THE LEAD THROUGH THE PACING SYSTEM ANALYZER (PSA) THE IMPEDANCE AND THRESHOLDS TESTED NORMAL. IMPEDANCE AND THRESHOLDS REMAINED NORMAL UPON RECONNECTING TO THE DEVICE. THE LEAD REMAINS IN USE. 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R 4196 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6947 IMPLANTABLE TACHY LEAD