BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3861813 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07174
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 28, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PARTIAL LEAD WAS RETURNED IN SEGMENTS AND ANALYZED AND NO ANOMALIES WERE FOUND. THE PROXIMAL AND DISTAL CONDUCTORS OF THE LEAD BECAME EXTRINSICALLY FRACTURED DUE TO A CUT. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. THE LEAD WAS DESTRUCTIVELY ANALYZED. NO ANOMALIES COULD BE ATTRIBUTED TO THE COMPLAINT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 PRODUCT: SEDR01, IPG, IMPLANTED: (B)(6) 2007. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT A CLINICAL DATA REVIEW REVEALED THAT THE RV LEAD IMPEDANCE TREND SHOWS A SUDDEN INCREASE IN IMPEDANCE OVER A PERIOD OF A FEW WEEKS TO OUT OF RANGE BETWEEN (B)(6) 2014. THE THRESHOLD TREND ALSO SHOWS A SUDDEN INCREASE IN THRESHOLD TO OVER 2.5 VOLTS OVER THE SAME TIME PERIOD FROM A STABLE THRESHOLD OF 0.625 VOLTS. THE VHR EPISODE LOG IS FULL OF EPISODES (FROM PRIOR TO LAST SESSION W/O EGM) FROM (B)(6) WITH THE FASTEST V RATE BEING OVER 450 BPM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS FRACTURED. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340334 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Hospitalization| R 1888TC ST JUDE LEAD