BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STOCKERT EP-SHUTTLE RADIO FREQUENCY GENERATOR

    MDR report key: 4384761 · Received January 6, 2015

    Report

    Report Number
    9612355-2015-00001
    Event Type
    Injury
    Date Received
    January 6, 2015
    Date of Event
    September 26, 2014
    Report Date
    December 23, 2014
    Manufacturer
    STOCKERT GMBH
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ¿SUSPECTED MEDICAL DEVICE¿ REPORTED IN SECTION D OF THIS REPORT IS NOT MARKETED IN USA OR APPROVED BY THE FDA. HOWEVER, IT IS BEING REPORTED AS BIOSENSE WEBSTER CONSIDERS THIS AS A SIMILAR DEVICE TO STOCKERT 70 RF GENERATOR APPROVED UNDER PMA # P990071. THE HARDWARE INVESTIGATION HAS BEGUN BUT IT HAS NOT BEEN COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT A FISTULA APPEARED ABOUT 4 WEEKS AFTER THE PROCEDURE. THE DEVICE WAS EVALUATED AND NO ERROR FOUND. DEVICE IS WITHIN SPECIFICATION. THE DEVICE WAS SUBJECTED TO THE PREVENTIVE MAINTENANCE, SAFETY AND FUNCTIONAL TESTING AND ALL TESTS PASSED. NO MALFUNCTION FOUND ON DEVICE. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT, UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A STOCKERT EP-SHUTTLE RADIO FREQUENCY GENERATOR AND 4 WEEKS AFTER THE PROCEDURE SUFFERED AN ESOPHAGEAL FISTULA WHICH REQUIRED OPERATION. THE PATIENT¿S MEDICAL HISTORY IS UNKNOWN. NO FURTHER INFORMATION IS KNOWN REGARDING THE PATIENT STATUS. 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
    6414 STOCKERT EP-SHUTTLE RADIO FREQUENCY GENERATOR SIMILAR DEVICE S7001, PMA # P990071 LPB STOCKERT GMBH 39D-76X

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R