BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 5711256 · Received June 9, 2016

    Report

    Report Number
    2649622-2016-05763
    Event Type
    Injury
    Date Received
    June 9, 2016
    Date of Event
    November 19, 2015
    Report Date
    March 17, 2016
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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 ATRIAL OVERSENSING, THE IMPEDANCE ON THE ATRIAL PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE, AND THE IMPEDANCE TREND ON THE ATRIAL PACING LEAD WAS RISING. ANALYST COMMENTED, ATRIAL PACE IMPEDANCE OUT OF RANGE HIGH ON (B)(6) AND (B)(6) 2016. ATRIAL PACE IMPEDANCE STEADILY RISES FROM 741 TO 1691 OHMS BETWEEN (B)(6) 2014 AND (B)(6) 2016. NON-PHYSIOLOGIC OVERSENSING DUE TO NOISE OBSERVED ON STORED ATRIAL LEAD ELECTROGRAM (EGM) FROM (B)(6) 2016.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE THE ATRIAL LEAD EXHIBITED HIGH IMPEDANCE, AND ATRIAL ELECTROGRAM INDICATED NOISE. THE ATRIAL LEAD WAS RE - PROGRAMMED/TURNED OFF AND REMAINS IN THE PATIENT. ADDITIONAL INFORMATION RECEIVED INDICATED A REPLACEMENT PROCEDURE WAS PERFORMED AND ATRIAL LEAD IMPEDANCE WAS 900-950 OHMS, AND THRESHOLD WAS 0.5V/0.4MS. FLUOROSCOPY DID NOT IDENTIFY LEAD FRACTURE BETWEEN THE SUBCLAVIAN AND THE LEAD TIP. NOISE OCCURRED WHEN THE POCKET SITE WAS TOUCHED, HOWEVER, THERE WAS NO CHANGE IN IMPEDANCE VALUE. INCOMPLETE LEAD FRACTURE IN THE POCKET WAS THEREFORE INFERRED. THE PATIENT WAS ADVANCED AGE WITH ALMOST BEDRIDDEN, AND THERE WAS NO NOISE WHEN THE PATIENT WAS RESTING. FOLLOWING UP HOSPITAL COMMENTED THAT ADDING A LEAD WAS NOT NEEDED. THE PHYSICIAN DECIDED THAT THE EXISTING LEAD REMAIN IN USE AND A NEW LEAD WAS NOT ADDED. FOLLOW-UP DEVICE CHECKS AT POST REPLACEMENT PROCEDURE IS TO BE CONDUCTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363989 CAPSURE Z NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5554-53

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R