BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STOCKERT EP-SHUTTLE RADIO FREQUENCY GENERATOR

    MDR report key: 3761232 · Received April 21, 2014

    Report

    Report Number
    9612355-2014-00021
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    March 26, 2014
    Report Date
    March 31, 2014
    Manufacturer
    STOCKERT GMBH
    Product Code
    DRF
    PMA / PMN Number
    P990071
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, THE DISPLAYED TEMPERATURE OF THE SMART TOUCH CATHETER WAS 53 DEGREE CELSIUS. THE ABLATION COULD BE CONDUCTED AT 53 DEGREE CELSIUS ALTHOUGH THE CUT-OFF WAS SET TO 44 DEGREE CELSIUS. AS THE PHYSICIAN NOTICED THE ISSUE, HE STOPPED THE ABLATION. AFTER THAT, THE TEMPERATURE CUT-OFF FUNCTION WAS ACTIVATED PROPERLY SPONTANEOUSLY AS THE TEMPERATURE DID NOT SOAR UNTIL 44 DEGREE CELSIUS. THE PROCEDURE WAS COMPLETED WITH USING THE CATHETER. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE. THE DEVICE WAS EVALUATED AND THE ISSUE WAS NOT REPRODUCIBLE. THE SYSTEM WAS REPLACED FOR PREVENTION PURPOSES. REPLACEMENT OF THE MODULE 331 WAS FOR PREVENTIVE PURPOSES. 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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION STILL IN PROGRESS. A SUPPLEMENTAL REPORT OR DEVICE EVALUATION WILL BE SUBMITTED. CONCOMITANT PRODUCT: SMART TOUCH BIDIRECTIONAL, MFG #: D-1327-05-S, LOT #: 16040760M. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, THE DISPLAYED TEMPERATURE OF THE SMART TOUCH CATHETER WAS 53 DEGREE CELSIUS. THE ABLATION COULD BE CONDUCTED AT 53 DEGREE CELSIUS ALTHOUGH THE CUT-OFF WAS SET TO 44 DEGREE CELSIUS. AS THE PHYSICIAN NOTICED THE ISSUE, HE STOPPED THE ABLATION. AFTER THAT, THE TEMPERATURE CUT-OFF FUNCTION WAS ACTIVATED PROPERLY SPONTANEOUSLY AS THE TEMPERATURE DID NOT SOAR UNTIL 44 DEGREE CELSIUS. THE PROCEDURE WAS COMPLETED WITH USING THE CATHETER. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE. PER THE EVENT DESCRIPTION STATING, "THE ABLATION COULD BE CONDUCTED AT 53 DEGREES CELSIUS ALTHOUGH THE CUT-OFF WAS SET TO 44 DEGREE CELSIUS" IS INDICATIVE OF A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240567 STOCKERT EP-SHUTTLE RADIO FREQUENCY GENERATOR RADIOFREQUENCY GENERATOR AND ACCESSORIES/ACCESSORY CABLE DRF STOCKERT GMBH 39D-76X

    Patients

    Seq Age Sex Outcome Treatment
    1