BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 4161619 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11475
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    August 24, 2014
    Report Date
    August 24, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN ASSISTANT

    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 WAS PERFORMED AND NO ANOMALIES WERE FOUND. ANALYST COMMENTED, NO ATRIAL CAPTURE MANAGEMENT (ACM) DATA - CANNOT RUN IN PACING MODE PROGRAMMED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT MEDICAL PRODUCTS: DDBB2D1, ICD, IMPLANTED: (B)(6) 2013. (B)(4).

    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 THE RIGHT VENTRICULAR (RV) HIGH VOLTAGE LEAD SHOWED VARYING IMPEDANCE AT THE RV CAN-RING AND A FRACTURE WAS SUSPECTED. IT WAS ALSO NOTED THAT A PATIENT ALERT HAD TRIGGERED. HIGH RATE NON SUSTAINED EPISODES OF 1-2 SECONDS DURATION OF NOISE WERE NOTED. THE RV LEAD WAS SCHEDULED FOR REVISION AT A LATER DATE. IN THE MEANTIME THE RV LEAD PACING AND SENSING POLARITIES WERE REPROGRAMMED TO RVTIP-COIL CONFIGURATION. IT WAS ALSO NOTED THAT THE ATRIAL LEAD EXHIBITED HIGH PACING THRESHOLD AND WAS THEREFORE REVISED AND REMAINS IN USE. DURING THE RV LEAD REVISION PROCEDURE IT WAS NOTED THAT THE PATIENT¿S VEIN WAS TOO NARROW FOR THE ADDITIONAL LEAD TO PASS THROUGH AND THEREFORE A DIFFERENT DF-4 SHOCK LEAD WAS TO BE IMPLANTED AND CONNECTED TO THE VR DEVICE. THE RV LEAD WAS CAPPED AND REMAINS IN THE PATIENT. IN ADDITION, THE PATIENT¿S PACING RATE WAS NOTED AS INCREASED, AND IT WAS DETERMINED THAT THE VR DEVICE WAS NOT ADEQUATE. THUS, THE EXISTING ICD SETTINGS WERE CHANGED TO AAIR 50/100, V PACING WITH ALL DETECTION TURNED OFF, AND A NEW ICD VR SYSTEM WAS THEN IMPLANTED TO THE RIGHT CHEST WITH A NON MDT DF4 LEAD CONNECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642041 CAPSUREFIX DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6940

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Hospitalization| R 6943 LEAD