BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RF MARINR

    MDR report key: 5119667 · Received October 1, 2015

    Report

    Report Number
    2182208-2015-03369
    Event Type
    Injury
    Date Received
    October 1, 2015
    Date of Event
    January 1, 2014
    Report Date
    August 20, 2015
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LPB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. MULTIPLE MANUFACTURERS WERE REFERENCED IN THE ARTICLE, BUT WITH NO MANUFACTURER DEVICE/PRODUCT FAILURE CORRELATION. THE GENDER OF THE BASELINE CHARACTERISTICS IS MALE AND THE BASELINE AGE IS 56 YEARS OLD. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: ¿INFLUENCE OF LEFT ATRIAL SIZE ON THE OUTCOME OF PULMONARY VEIN ISOLATION IN PATIENTS WITH ATRIAL FIBRILLATION.¿ KARDIOLOGIA POLSKA 2014; 72, 11: 1135¿1140. (B)(4)

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING AN ABLATION CATHETER. MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. THE ARTICLE REPORTS THAT THERE WERE THE FOLLOWING COMPLICATIONS DURING THE ABLATION PROCEDURES: ONE PATIENT HAD CARDIAC PERFORATION AND SUBSEQUENT CARDIAC TAMPONADE AND ONE PATIENT EXPERIENCED A CEREBRAL STROKE 14 MONTHS AFTER THE PROCEDURE. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647019 RF MARINR CARDIAC ABLATION PERCUTANEOUS CATHETER LPB MEDTRONIC, INC. FA075302

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Hospitalization| L| R