BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARINR

    MDR report key: 6807943 · Received August 21, 2017

    Report

    Report Number
    3002648230-2017-00453
    Event Type
    Injury
    Date Received
    August 21, 2017
    Date of Event
    January 1, 2004
    Report Date
    July 25, 2017
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    LPB
    PMA / PMN Number
    P930029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC 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. THIS EVENT OCCURRED OUTSIDE THE US. 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 OF THE PATIENTS REPRESENTED IN THE ARTICLE IS FEMALE/51 YEARS OLD. THE MODEL LISTED IN THE REPORT IS A REPRESENTATIVE, AS THERE IS NO SPECIFIC MODEL LISTED. 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: ¿TRANSVENOUS CRYOABLATION VERSUS RADIOFREQUENCY ABLATION OF THE SLOW PATHWAY FOR THE TREATMENT OF ATRIOVENTRICULAR NODAL RE-ENTRANT TACHYCARDIA: A PROSPECTIVE RANDOMIZED PILOT STUDY.¿EUROPEAN HEART JOURNAL (2004) 25, 2226¿2231. DOI:10.1016/J.EHJ.2004.07.020. 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 COMPLICATIONS WHILE USING A RADIO FREQUENCY ABLATION CATHETER: THERE WAS ONE (1) PATIENT WHO SUFFERED FROM PERMANENT 1ST DEGREE ATRIOVENTRICULAR (AV) BLOCK; ¿ALTHOUGH THE ENERGY DELIVERY WAS TERMINATED AFTER 1.3 SECONDS.¿ THE STATUS/LOCATION OF THE CATHETER 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
    589116 MARINR CARDIAC ABLATION PERCUTANEOUS CATHETER LPB MEDTRONIC CRYOCATH LP 075305

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other