BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP NOVUS LEAD

    MDR report key: 2952435 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00542
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    October 1, 2012
    Report Date
    June 18, 2019
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. CONCOMITANT PRODUCTS: C4TR01 IMPLANTABLE PULSE GENERATOR (IPG) (B)(6) 2011; 4976 IMPLANTABLE PACING LEAD (B)(6) 2011. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS; HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE OF THE ATRIAL PACING LEAD WAS BELOW THE EXPECTED LOWER RANGE. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE TREND OF THE ATRIAL PACING LEAD WAS VARIABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LEAD WARNING ON THE RIGHT ATRIAL (RA) LEAD. THE BIPOLAR IMPEDANCE WAS LOW AND UNIPOLAR IMPEDANCE WAS HIGHER THAN BIPOLAR. IT WAS ALSO REPORTED THAT THERE WAS OVERSENSING IN BIPOLAR, AND THERE WAS POTENTIALLY AN INSULATION ISSUE. IT WAS NOTED THAT THE PATIENT FEELS PACING WHEN IN UNIPOLAR CONFIGURATION. THE LEAD WAS LEFT IN BIPOLAR CONFIGURATION AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE LEAD CONTINUED TO EXHIBIT LOW PACING IMPEDANCE IN ADDITION TO UNSTABLE PACING THRESHOLDS. THRESHOLDS WERE DIFFERENT WITH THE PATIENT'S ARM AT REST VERSUS ACROSS THEIR CHEST. THRESHOLDS AND IMPEDANCE WERE NORMAL IN A SITTING POSITION BUT LOW IMPEDANCE COULD BE REPRODUCED BY HAVING THE PATIENT MOVE THEIR LEFT ARM ACROSS THEIR CHEST TO THEIR RIGHT SHOULDER. THE PATIENT FELT THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) MOVED A GREAT DEAL IN THE POCKET BUT THIS WAS NOT DUE TO TWIDDLER'S SYNDROME AND THE DEVICE COULD NOT BE FLIPPED IN THE POCKET. NO ACTION WAS TAKEN. THE PATIENT WILL CONTINUE TO BE MONITORED AND A NEW ATRIAL LEAD WILL BE CONSIDERED AT THE NEXT GENERATOR CHANGE. THE LEAD AND DEVICE REMAIN IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56675 CAPSURE SP NOVUS LEAD ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4592-53

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR 4193 IMPLANTABLE PACING LEAD