BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2964393 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-01538
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    March 25, 2015
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    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. CONCOMITANT PRODUCTS: 5076 IMPLANTABLE PACING LEAD 2006 (B)(6); 310C27 TISSUE VALVE 2012 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY - THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. AUTO LEAD DIAGNOSTICS SHOWS MAXIMUM VENTRICULAR LEAD IMPEDANCE GREATER THAN 9,999 OHMS THROUGHOUT THE RECORD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS SUSPECTED TO HAVE FRACTURED, AND THAT BOTH LEAD IMPEDANCE AND LEAD NOISE INDICATED A LEAD FRACTURE. IT WAS ALSO REPORTED THAT THERE WAS A VENTRICULAR LEAD WARNING FOR HIGH THRESHOLD AND VENTRICULAR HIGH RATES WHICH SHOWED AS NOISE ON THE ELECTROGRAM (EGM.) IT WAS FURTHER REPORTED THAT DURING RV LEAD REPLACEMENT THE MD DETERMINED THAT THE PATIENT WAS OCCLUDED AND DECIDED NOT TO REPLACE THE RV LEAD SINCE THE PATIENT WAS RARELY PACED IN THE VENTRICLE. THEREFORE THE RV LEAD WAS LEFT IN PLACE AND REPROGRAMMING DONE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT BOTH THE ATRIAL AND RIGHT VENTRICULAR LEADS WERE EXPLANTED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD INCREASED AND RISING THRESHOLD AND RECENTLY NON-CAPTURE AT HIGH OUTPUTS. THE LEAD WAS ALSO OBSERVED TO HAVE OVERSENSING, UNDERSENSING AND UNDEFINED IMPEDANCE. THE PATIENT ALSO HAD COMPLAINTS OF INTERMITTENT POCKET STIMULATION AFTER THE REPROGRAMMING. THE DEVICE WAS SUBSEQUENTLY EXPLANTED AND REPLACED DUE TO THE ASSOCIATED LEAD ISSUES. WHEN THE LEADS WERE DISCONNECTED FROM THE DEVICE AND THE VENTRICULAR LEAD WAS TESTED VIA THE ANALYZER, THE MEASUREMENTS WERE NORMAL. NO OBVIOUS ISSUES WITH THE HEADER WERE SEEN, HOWEVER IT IS SPECULATED THAT A CONNECTION/SETSCREW ISSUE MAY HAVE BEEN PRE-EXISTING AND WAS RESPONSIBLE FOR THE LEAD ISSUES. THE RIGHT VENTRICULAR LEAD REMAINS IN USE. IN ADDITION, THE ATRIAL CAPTURE MANAGEMENT EXHIBITED HIGH THRESHOLD/OUTPUT CONDITIONS FOR SEVERAL MONTHS. THERE MAY HAVE BEEN FAR-FIELD SENSING OF UNIPOLAR VENTRICULAR PACING CONTRIBUTING TO THE INACCURACY OF THE ATRIAL CAPTURE MANAGEMENT. THE ATRIAL LEAD WAS CONNECTED TO THE NEW DEVICE AND REMAINS IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66950 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Hospitalization| R E2DR01 IMPLANTABLE PACEMAKER