BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1865047 · Received October 12, 2010

    Report

    Report Number
    2649622-2010-10868
    Event Type
    Injury
    Date Received
    October 12, 2010
    Date of Event
    July 28, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Removal / Correction Number
    ASKU
    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 FREQUENT LOSS OF ATRIAL AND VENTRICULAR CAPTURE WAS SEEN ON TELEMETRY SOON AFTER A DEVICE REVISION WAS PERFORMED. THE PATIENT IS PACEMAKER DEPENDENT AND THERE WAS NO CAPTURE WHEN DEVICE IS PROGRAMMED UNIPOLAR. BOTH THE ATRIAL AND VENTRICULAR IMPEDANCES DROPPED APPROXIMATELY 100 OHMS IN BIPOLAR MODE. IT ALSO WAS REPORTED THAT NEITHER LEAD WOULD PACE OR SENSE THROUGH THE ANALYZER. BOTH LEADS WERE SEEN DISLODGED UNDER FLUOROSCOPY. BOTH THE LEADS WERE REPLACED. 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 89 YR Required Intervention VEDR01 IMPLANTABLE PULSE GENERATOR