BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARINR

    MDR report key: 6781012 · Received August 9, 2017

    Report

    Report Number
    3002648230-2017-00434
    Event Type
    Injury
    Date Received
    August 9, 2017
    Date of Event
    March 1, 2002
    Report Date
    June 26, 2017
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    LPB
    PMA / PMN Number
    P930029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 U.S. MULTIPLE MANUFACTURERS WERE REFERENCED IN THE ARTICLE; WITH NO SPECIFICS PROVIDED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. 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: ¿CATHETER ABLATION AND ANTIARRHYTHMIC DRUGS FOR HAEMODYNAMICALLY TOLERATED POST-INFARCTION VENTRICULAR TACHYCARDIA.¿ EUR HEART J 2001, 23: 414¿424, DOI:10.1053/EUHJ.2001.2804. 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 RADIO FREQUENCY(RF) ABLATION CATHETER, OF NOTE, THERE WERE MULTIPLE MANUFACTURERS REFERENCED IN THE ARTICLE. THERE WERE COMPLICATIONS WHICH INCLUDED: ¿ONE TRANSIENT ISCHEMIC ATTACK WITH FULL RECOVERY AND NO NEUROLOGICAL SEQUELAE; TWO PERIPHERAL EMBOLI; ONE COMPLETE ATRIOVENTRICULAR BLOCK REQUIRING PACEMAKER IMPLANT; RAPID VENTRICULAR TACHYCARDIAS REQUIRING DC CARDIOVERSION, WITHIN 48 H OF ABLATION." THE STATUS/LOCATION OF THE RF 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
    558750 MARINR CARDIAC ABLATION PERCUTANEOUS CATHETER LPB MEDTRONIC CRYOCATH LP FA075302

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L| R