BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPIA MRI QUAD CRT-D

    MDR report key: 7621079 · Received June 20, 2018

    Report

    Report Number
    9614453-2018-02307
    Event Type
    Malfunction
    Date Received
    June 20, 2018
    Date of Event
    June 6, 2018
    Report Date
    October 4, 2018
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. RETURNED PRODUCT ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. RETURNED PRODUCT ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    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 THE IMPLANT PROCEDURE, THE RIGHT VENTRICULAR (RV) LEAD COULD NOT BE SCREWED IN THE CONNECTOR OF THE DEVICE. AFTER SEVERAL TRIALS, THE SILICONE PART AND INNER SYSTEM WERE EXTRACTED TO SCREW THE LEAD VIA LEAD ADAPTER KIT WHICH INCLUDES SILICONE AND REPAIR KIT. HOWEVER, THE NEW SCREW COULD NOT BE PUT IN THE CONNECTOR PROPERLY. THE LEAD FUNCTIONALITY WAS CHECKED THROUGH ANALYZER AND THE DEVICE WAS CHANGED WITH THE NEW ONE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465154 COMPIA MRI QUAD CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC EUROPE SARL DTMC2QQ

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR