BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARIA MRI QUAD CRT-D SURESCAN

    MDR report key: 10232459 · Received July 6, 2020

    Report

    Report Number
    3004209178-2020-11410
    Event Type
    Malfunction
    Date Received
    July 6, 2020
    Date of Event
    May 1, 2020
    Report Date
    July 6, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NIK
    UDI-DI
    00643169837669
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 5076-52, LEAD, IMPLANTED (B)(6) 2017; 459888, LEAD, IMPLANTED (B)(6) 2019. (B)(4). DATE USER FACILITY BECAME AWARE OF EVENT: UNKNOWN. TYPE OF REPORT: INITIAL. DATE OF THIS REPORT: 05/XX/2020. APPROXIMATE AGE OF DEVICE: 1 YEAR. LOCATION WHERE EVENT OCCURRED: HOME. REPORT SENT TO MANUFACTURER: YES; 05-2020. MANUFACTURER NAME AND ADDRESS MFR. MEDTRONIC: PLC. ADDL: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD INTERMEDIATE INTERRUPTIONS DUE TO UNINTENTIONAL MAGNET REVERSION FROM AN ELECTRONIC CIGARETTE BEING PLACED ADJACENT TO THE DEVICE IN A SHIRT POCKET. THE DEVICE IS STILL 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
    696126 CLARIA MRI QUAD CRT-D SURESCAN DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC PUERTO RICO OPERATIONS CO. DTMA1Q1 00643169837669

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR 694765 LEAD