BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2131569 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10661
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 21, 2007
    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
    PA, 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 THERE WAS HIGH IMPEDANCE OF GREATER THAN 3000 OHMS. A NEW LEAD WAS PLACED IN THE RIGHT VENTRICLE FOR PACING/SENSING. THE HIGH VOLTAGE PORTION OF THIS LEAD REMAIN IN USE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT THAT SHE WAS UNABLE TO SLEEP, AND HER HANDS FELT 'TINGLY'. IT WAS LATER REPORTED THAT PACING/SENSING LEAD WAS SENSING NOISE AND OVERSENSING. THE LEAD WAS EXPLANTED AND REPLACED AND THE HIGH VOLTAGE PORTION OF THE ORIGINAL LEAD WAS EXPLANTED AND REPLACED AS WELL. DURING THE EXTRACTION, THE ATRIAL LEAD WAS DAMAGED AND IT WAS PARTIALLY REMOVED AND 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. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| R 7278 IMPLANTABLE PACEMAKER/CARDIO/DEFIB