BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STOCKERT 70 RF GENERATOR

    MDR report key: 3213941 · Received July 9, 2013

    Report

    Report Number
    9612355-2013-00033
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 12, 2013
    Manufacturer
    STOCKERT GMBH
    Product Code
    DRF
    PMA / PMN Number
    P990071
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION STILL IN PROGRESS. A SUPPLEMENTAL REPORT OR DEVICE EVALUATION WILL BE SUBMITTED. BIOSENSE WEBSTER MANUFACTURER'S REF. NO.'S (B)(4) ARE RELATED TO THE SAME INCIDENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, THE TEMPERATURE READING WAS ONLY 9 DEGREES CELSIUS DURING ABLATION. THE REDEL CABLE WAS REPLACED AND THE TEMPERATURE READING DECREASED FURTHER TO 6 DEGREES CELSIUS. WHEN THE CATHETER WAS REPLACED, THE ISSUE WAS RESOLVED. UPON REQUEST, THE BWI FIELD REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION ON THE EVENT. ABLATION WAS DELIVERED AT THE SET POWER AND THE SIGNAL WAS DIMINISHING. THE BASELINE TEMPERATURE ON THE STOCKERT WHEN THEY STARTED TO ABLATE WAS REFLECTING 7DEGREES. THE ABLATION WAS DELIVERED WHEN THE STOCKERT WAS READING 9 DEGREES. THE PHYSICIAN LAID SEVERAL LESIONS THIS WAY AND THOUGHT THEY WERE ADEQUATE. THE GENERATOR WAS IN POWER CONTROL MODE. THERE WERE NO ERROR MESSAGES OR WARNINGS. NO REPORTED PATIENT CONSEQUENCE. AFTER SEVERAL ATTEMPTS TO FOLLOW UP WITH CUSTOMER, THE CALL IS GOING TO BE CLOSED SINCE THE CUSTOMER HAS NOT RESPONDED BACK IN REGARDS TO TICKET. THE DEVICE HISTORY RECORD (DHR) FOR THE STOCKERT GENERATOR SERIAL NUMBER (B)(4) SHOWS THAT NO MANUFACTURING OR TEST FAILS WERE NOTED DURING THE MANUFACTURING CYCLE RELATED TO FUNCTIONALITY OF THE DEVICE. THE DEVICE MET ALL REQUIREMENTS PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, THE TEMPERATURE READING WAS ONLY 9 DEGREES CELSIUS DURING ABLATION. THE REDEL CABLE WAS REPLACED AND THE TEMPERATURE READING DECREASED FURTHER TO 6 DEGREES CELSIUS. WHEN THE CATHETER WAS REPLACED, THE ISSUE WAS RESOLVED. UPON REQUEST, THE BWI FIELD REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION ON THE EVENT. ABLATION WAS DELIVERED AT THE SET POWER AND THE SIGNAL WAS DIMINISHING. THE BASELINE TEMPERATURE ON THE STOCKERT WHEN THEY STARTED TO ABLATE WAS REFLECTING 7DEGREES. THE ABLATION WAS DELIVERED WHEN THE STOCKERT WAS READING 9 DEGREES. THE PHYSICIAN LAID SEVERAL LESIONS THIS WAY AND THOUGHT THEY WERE ADEQUATE. THE GENERATOR WAS IN POWER CONTROL MODE. THERE WERE NO ERROR MESSAGES OR WARNINGS. NO REPORTED PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312521 STOCKERT 70 RF GENERATOR RADIOFREQUENCY GENERATOR AND ACCESSORIES/ACCESSORY CABLE DRF STOCKERT GMBH M-5463-01

    Patients

    Seq Age Sex Outcome Treatment
    1