BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIMILAR DEVICE NS7TCBL174HS, PMA # P990025

    MDR report key: 5651613 · Received May 12, 2016

    Report

    Report Number
    2029046-2016-00046
    Event Type
    Death
    Date Received
    May 12, 2016
    Date of Event
    January 1, 2016
    Report Date
    April 22, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (IRWINDALE)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. SINCE THE LOT NUMBER IS UNKNOWN, THE FULL UDI NUMBER CAN NOT BE PROVIDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE ABOUT 4 TO 5 MONTHS AGO WITH AN EP-SHUTTLE RF GENERATOR SYSTEM-100W AND A NAVISTAR CATHETER. THE PATIENT DEVELOPED AN ESOPHAGEAL FISTULA. THE PATIENT EXPIRED 2 TO 3 MONTHS AFTER THE PROCEDURE AT A DIFFERENT HOSPITAL THAN WHERE THE ABLATION WAS PERFORMED. THERE IS NO INFORMATION ABOUT THE HOSPITALIZATION AND IF ANY INTERVENTION WAS PERFORMED. THE PHYSICIAN'S OPINION FOR THE CAUSE OF THIS ADVERSE EVENT IS UNKNOWN. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305113 SIMILAR DEVICE NS7TCBL174HS, PMA # P990025 LPB BIOSENSE WEBSTER, INC. (IRWINDALE) D-1183-00 UNKNOWN_NAVISTAR TC

    Patients

    Seq Age Sex Outcome Treatment
    1 Death