BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STOCKERT 70 RF GENERATOR

    MDR report key: 5795363 · Received July 14, 2016

    Report

    Report Number
    9612355-2016-00042
    Event Type
    Injury
    Date Received
    July 14, 2016
    Date of Event
    June 21, 2016
    Report Date
    June 21, 2016
    Manufacturer
    STOCKERT GMBH
    Product Code
    DRF
    PMA / PMN Number
    P990071
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING WAS OMITTED FROM THE INITIAL REPORT IN ERROR: THIS STOCKERT WAS MANUFACTURED BEFORE SEPTEMBER 24, 2014, THEREFORE NO UDI IS APPLICABLE FOR THIS PRODUCT WITH SERIAL NUMBER (B)(4). MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    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. CONCOMITANT PRODUCTS: CARTO 3 SYSTEM, MODEL #M-4800-01, S/N: (B)(4). COOLFLOW PUMP, MODEL #M-5491-02, S/N: (B)(4). EZ STEER THERMOCOOL SF NAV, MODEL #D-1313-04-S. WEBSTER CS CATHETER, MODEL #D-1353-04-S. (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A STOCKERT 70 SYSTEM RADIOFREQUENCY GENERATOR AND SUFFERED SECOND DEGREE BURNS REQUIRING NO MEDICAL OR SURGICAL INTERVENTION REPAIR FOLLOW-UP WAS PERFORMED, BUT SERVICE WAS DECLINED AND THE DEVICE WAS NOT SHIPPED. THE COMPLAINT IS NOT ABLE TO BE CONFIRMED. A DEVICE HISTORY RECORD (DHR) REVIEW VERIFIED 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 ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A STOCKERT 70 SYSTEM RADIOFREQUENCY GENERATOR AND SUFFERED BURNS SECOND DEGREE REQUIRING NO MEDICAL OR SURGICAL INTERVENTION. AFTER THE PROCEDURE, BLISTERS WERE OBSERVED ON THE PATIENT'S SKIN WHERE THE GROUNDING PAD HAD BEEN PLACED. PATIENT WAS REPORTED TO BE IN STABLE CONDITION. PHYSICIAN DID NOT PROVIDE A CAUSALITY OPINION. 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
    448478 STOCKERT 70 RF GENERATOR RADIOFREQUENCY GENERATOR AND ACCESSORIES/ACCESSORY CABLE DRF STOCKERT GMBH M-5463-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other