BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXABILITY¿ ABLATION CATHETER, SENSOR ENABLED¿

    MDR report key: 17737088 · Received September 13, 2023

    Report

    Report Number
    3005334138-2023-00386
    Event Type
    Injury
    Date Received
    September 13, 2023
    Date of Event
    August 21, 2023
    Report Date
    November 14, 2023
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OAD
    PMA / PMN Number
    P110016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    AFTER A REPEAT ABLATION PROCEDURE ON (B)(6) 2023, THE PATIENT REPORTED TRANSIENT SCINTILLATING SCOTOMA. A BRAIN COMPUTED TOMOGRAPHY WAS PERFORMED WITH NEGATIVE RESULTS. THE NEUROLOGIST DIAGNOSED A SUSPECTED TRANSIENT ISCHEMIC ATTACK. PERMANENT INTAKE OF NON-VITAMIN K ANTAGONIST ORAL ANTICOAGULANTS WAS RECOMMENDED. THE SYMPTOMS RESOLVED WITHOUT SEQUELAE AND THE PATIENT WAS DISCHARGED ON (B)(6) 2023. AE REL TO ABLATION PROCEDURE: Y. AE REL TO DEVICE UNDER STUDY: N. AE REL TO IMPLANT PROCEDURE: N. AE RELATED TO COVID: NOT RELATED. EVENT DESCRIPTION: TRANSIENT ISCHEMIC ATTACK (TIA). EVENT DESCRIPTION- OTHER, SPEC: AE EVENT DETAILS: AFTER REPEAT ABLATION PROCEDURE ON (B)(6) 2023 PATIENT REPORTED TRANSIENT SCINTILLATING SCOTOMA. NO FINDINGS IN BRAIN CT. NEUROLOGIST DIAGNOSED SUSPECTED TIA. PERMANENT INTAKE OF NOAC RECOMMENDED. PATIENT DISCHARGED ON (B)(6) 2023. PATIENT'S ETHNICITY: PATIENT'S RACE: PATIENT NUMBER: (B)(6). CLINICAL STUDY PATIENT ID: (B)(6). STATUS OF ADVERSE EVENT: RESOLVED WITHOUT SEQUELAE.

    Description of Event or Problem · 0

    CORRECTED REPORT NEEDED TO REFLECT CORRECTED MANUFACTURING SITES AS COSTA RICA.

    Description of Event or Problem · 0

    THIS REPORT IS TO REFLECT UPDATED INFORMATION RECEIVED FROM THE REPORTING PERSON WHICH INDICATES THAT NO ABBOTT DEVICE USED IN THIS PROCEDURE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT MAKING THIS NOT REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76622 FLEXABILITY¿ ABLATION CATHETER, SENSOR ENABLED¿ CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD ST. JUDE MEDICAL A-FASE-F

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| L