BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARINR

    MDR report key: 6136158 · Received November 30, 2016

    Report

    Report Number
    2182208-2016-02608
    Event Type
    Injury
    Date Received
    November 30, 2016
    Date of Event
    August 23, 2016
    Report Date
    October 31, 2016
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LPB
    PMA / PMN Number
    P930029
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. 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 BASELINE GENDER/AGE OF THE PATIENTS IS MALE/55 YEARS OF AGE. 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: MANAGEMENT AND OUTCOME OF PERIPROCEDURAL CARDIAC PERFORATION AND TAMPONADE WITH RADIOFREQUENCY CATHETER ABLATION OF CARDIAC ARRHYTHMIAS: A SINGLE MEDIUM-VOLUME CENTER EXPERIENCE. ADV THER. 2016;33(10):1782-1796. 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH REPORTED THE FOLLOWING PATIENT COMPLICATION AND PRODUCT PERFORMANCE ISSUE WHILE USING THE RADIO FREQUENCY (RF) ABLATION CATHETER SYSTEM. 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 INDICATED THAT THERE WERE PATIENTS WHO EXPERIENCED CARDIAC TAMPONADE AS A RESULT OF CARDIAC PERFORATION WHICH WAS ATTRIBUTED TO "CATHETER MANIPULATION" OR ¿EXCESSIVE RF ABLATION.¿ PATIENTS WERE TREATED WITH PERICARDIOCENTESIS. TWO (2) PATIENTS NEEDED "URGENT SURGERY" DUE TO "CONTINUOUS BLEEDING,¿ AND THE SUSPICION OF ¿HOLLOW ORGAN PERFORATION.¿ THERE WERE TWO (2) PATIENTS IN WHOM THE TAMPONADE RESULTED IN "ELECTROMECHANICAL DISASSOCIATION" AND "CARDIO-RESPIRATORY ARREST." THERE WAS ONE (1) PATIENT WHO DEVELOPED SEPSIS AFTER THE PERICARDIOCENTESIS. MANY PATIENTS WERE TREATED WITH MEDICATION AND/OR ¿AUTO-TRANSFUSIONS.¿ THE STATUS/LOCATION OF THE SYSTEM 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
    784957 MARINR CARDIAC ABLATION PERCUTANEOUS CATHETER LPB MEDTRONIC, INC. 075305

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L| R