BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2813042 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16720
    Event Type
    Injury
    Date Received
    October 31, 2012
    Report Date
    February 13, 2013
    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
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE ACTUAL LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ALERTS: LEAD ALERT FOR RV Z > 3000 OHMS PRESENTED ON PROGRAMMER. IMPEDANCE/HIGH IMPEDANCE: RV LEAD IMPEDANCE 300-400 OHMS PRIOR TO (B)(4)-2012. STEADILY INCREASING OVER NEXT 34 WEEKS, BREAKING 3000 OHMS WEEK ENDING (B)(4)-2012. DAILY IMPEDANCES > 3K OHMS SINCE (B)(4)-2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A SLOW, STEADY RISE IN IMPEDANCE TO HIGH LEVELS. THE PATIENT WILL CONTINUE TO BE MONITORED, AND THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A SLOW, STEADY RISE IN IMPEDANCE TO HIGH LEVELS. THE PATIENT WILL CONTINUE TO BE MONITORED, AND THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE LEAD WAS POSSIBLY FRACTURED. THE LEAD WAS CAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC PUERTO RICO, INC. 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Hospitalization| O| R 5076 IMPLANTABLE PACING LEAD