BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3860773 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-05306
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    March 17, 2014
    Report Date
    March 17, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY- THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER). IT WAS NOTED AUTOMATIC LEAD DIAGNOSTICS SHOWS VENTRICULAR NON-PHYSIOLOGICAL SENSING COUNTS AND APPARENT NOISE IN VENTRICULAR HIGH RATE EPISODES.

    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: 5076-45 IMPLANTABLE PACING LEAD, (B)(6) 2007. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PERFORMANCE DATA SHOWED ATRIAL HIGH RATE AND VENTRICULAR HIGH RATE EPISODES WITH NON-PHYSIOLOGIC SENSING. THIS WAS REPRODUCIBLE IN THE CLINIC WITH LEFT ARM MOTION. IT WAS NOTED THAT IMPEDANCES AND CAPTURE THRESHOLDS WERE STABLE. IT WAS ALSO REPORTED THAT THERE WAS A "SUSPECTED OUTER INSULATION BREACH ON BOTH LEADS" , ABRASION LIKELY AS NOISE ON BOTH LEADS AS WELL. BOTH LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338747 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC PUERTO RICO 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR ADDR01 PACEMAKER