BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEZOR CARDIAC CRYOABLATION CATHETER

    MDR report key: 6715373 · Received July 14, 2017

    Report

    Report Number
    3002648230-2017-00365
    Event Type
    Injury
    Date Received
    July 14, 2017
    Date of Event
    May 1, 2006
    Report Date
    June 21, 2017
    Manufacturer
    MEDTRONIC, PLC
    Product Code
    LPB
    PMA / PMN Number
    P020045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC CRYOCATH WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC PATIENT OR DEVICE INFORMATION FROM THE LITERATURE PUBLICATION OR TO MATCH THE EVENT WITH PREVIOUSLY REPORTED EVENTS. THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT LOT NUMBERS. THE BASELINE GENDER/AGE CHARACTERISTIC IS FEMALE/14 YEARS OLD WITH A MEAN WEIGHT OF 55 KG, FOR THE PATIENTS REFERENCED IN THE ARTICLE. 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. REFERENCED ARTICLE: ¿CRYOABLATION VERSUS RADIOFREQUENCY ABLATION FOR TREATMENT OF PEDIATRIC ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA: INITIAL EXPERIENCE WITH 4-MM CRYOCATHETER.¿ HEART RHYTHM 2006; 3:564 ¿570.A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE LITERATURE PUBLICATION REPORTS THE FOLLOWING PATIENT COMPLICATION WHILE USING A CRYOABLATION CATHETER: THERE WAS ONE PATIENT WHO CONTINUED TO HAVE FIRST DEGREE AV BLOCK AFTER ABLATION, WITH UNKNOWN TREATMENT/RESOLUTION. THE STATUS/LOCATION OF THE CATHETER/CONSOLE IS UNKNOWN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494528 FREEZOR CARDIAC CRYOABLATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB MEDTRONIC, PLC 207F1

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization| O CRYOCONSOLE