BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 7221620 · Received January 26, 2018

    Report

    Report Number
    2182208-2018-00019
    Event Type
    Injury
    Date Received
    January 26, 2018
    Date of Event
    January 1, 2017
    Report Date
    January 26, 2018
    Manufacturer
    MEDTRONIC, PLC
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    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 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. THE BASELINE GENDER/AGE OF THE PATIENTS REPRESENTED IN THE ARTICLE IS MALE/14 YEARS OLD. THE BASELINE WEIGHT OF THE REFERENCED PATIENTS IS 50 KG. OF NOTE, MULTIPLE PATIENTS/MANUFACTURERS/METHODS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE MANUFACTURER/METHODS/PRODUCT LOT NUMBERS. THE MODEL LISTED IN THE REPORT IS A REPRESENTATIVE OF THE MODEL FAMILY, 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: ¿EPICARDIAL ABLATION OF TACHYARRHYTHMIA IN CHILDREN: EXPERIENCE AT TWO ACADEMIC CENTERS.¿ PACING CLIN ELECTROPHYSIOL. 2017;40:1017¿1026. DOI: 10.1111/PACE.13152. 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 AN ABLATION CATHETER: THERE WERE FOUR (4) PATIENTS WHO EXPERIENCED COMPLICATIONS: ONE PATIENT HAD CHEST PAIN THE DAY AFTER THE ATTEMPTED PROCEDURE, AND PERICARDIAL EFFUSION AND SEROMA AT FOLLOW UP. OF NOTE THIS PATIENT DID NOT HAVE THE ABLATION PROCEDURE DUE TO CATHETER ¿MANUERVABILITY¿ AROUND PREVIOUS SCAR TISSUE. ANOTHER PATIENT HAD ¿INADVERTENT ENTRY INTO THE LEFT PLEURAL SPACE;¿ OF WHICH THERE WAS NO REQUIRED TREATMENT. THE THIRD PATIENT HAD NARROWING OF THE ARTERY, SUBSEQUENT CARDIAC ARREST DURING THE PROCEDURE, WHICH REQUIRED CARDIOVERSION, AND AN ¿AGGRESSIVE¿ ABLATION TREATMENT DUE TO THE ARRHYTHMIAS. THE FOURTH PATIENT HAD ¿TRANSIENT¿ LEFT BUNDLE BRANCH BLOCK (LBBB) WITH UNKNOWN TREATMENT/RESOLUTION. OF NOTE, MULTIPLE PATIENTS/ MANUFACTURERS/METHODS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE MANUFACTURER/METHOD/PRODUCT LOT NUMBERS. THE STATUS/LOCATION OF THE ABLATION 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
    64928 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, PLC MDT-UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization| L| R