BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INQUIRY¿ ELECTROPHYSIOLOGY STEERABLE CATHETER

    MDR report key: 8180218 · Received December 19, 2018

    Report

    Report Number
    2030404-2018-00085
    Event Type
    Injury
    Date Received
    December 19, 2018
    Date of Event
    December 7, 2018
    Report Date
    December 19, 2018
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DRF
    PMA / PMN Number
    K961924
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS.  ADDITIONALLY, NO LOT NUMBER WAS PROVIDED SO A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED HEART BLOCK COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    RELATED MANUFACTURING REF: 2030404-2018-00086, 2030404-2018-00087. DURING AN ATRIOVENTRICULAR NODAL REENTRY TACHYCARDIA PROCEDURE, A SELF-RESOLVING HEART BLOCK OCCURRED THAT LASTED APPROXIMATELY 8 SECONDS SHORTLY AFTER A SECOND CRYO LESION. NO INTERVENTION WAS NEEDED FOR THE HEART BLOCK. THE PROCEDURE WAS CANCELLED BUT SUFFICIENT LESIONS HAD BEEN PERFORMED PRIOR TO THE CANCELLATION. THE PATIENT IS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1018630 INQUIRY¿ ELECTROPHYSIOLOGY STEERABLE CATHETER CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF ST. JUDE MEDICAL, INC. IBI-81402

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other INQUIRY¿ ELECTROPHYSIOLOGY STEERABLE CATHETER| INQUIRY¿ ELECTROPHYSIOLOGY STEERABLE CATHETER| MEDTRONIC FREEZOR MAX CRYOCATH