BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STOCKERT 70 RF GENERATOR

    MDR report key: 5288316 · Received December 11, 2015

    Report

    Report Number
    9612355-2015-00063
    Event Type
    Injury
    Date Received
    December 11, 2015
    Date of Event
    November 10, 2015
    Report Date
    November 11, 2015
    Manufacturer
    STOCKERT GMBH
    Product Code
    DRF
    PMA / PMN Number
    P990071
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    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. (B)(4). CONCOMITANT PRODUCT: 1.CARTO 3 SYSTEM: MODEL #: M-4800-01, SERIAL #:(B)(4). 2.COOL FLOW PUMP: MODEL #: M-5491-02, SERIAL #:(B)(4). 3.SMART TOUCH BIDIRECTIONAL CATHETER: MODEL #: D-1327-05-S, LOT #: 17299194M. 4.PENTARAY NAV ECO CATHETER: MODEL #: UNKNOWN, LOT #: UNKNOWN. 5.WEBSTER CS CATHETER : MODEL #: UNKNOWN, LOT #: UNKNOWN. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL CLARIFICATION WAS RECEIVED ON THE EVENT. THE PATIENT DID NOT RECEIVE SURGERY, BUT DID HAVE ONGOING WOUND CARE. IT WAS STATED THAT THERE WAS LIKELY SOME EXTENSION OF HOSPITALIZATION. HOWEVER, IT WAS POSSIBLE THAT IT WAS HANDLED IN AN OUTPATIENT BASIS. DUE TO THE AUGUST 2015 FDA MAINTENANCE WERE THE 3500A CODES WERE UPDATED, THE 3500A CODES WILL BE ADDED UNTIL THE BIOSENSE WEBSTER SYSTEM IS ALSO UPDATED. (B)(4). IT WAS REPORTED THAT A PATIENT UNDERWENT A PERSISTENT ATRIAL FIBRILLATION PROCEDURE WITH A STOCKERT 70 SYSTEM AND SUSTAINED A SECOND DEGREE BURN. THE PATCH HAD BEEN PLACED WHILE ON THE GURNEY BY HOSPITAL STAFF PRIOR TO BEING TRANSFERRED TO THE OPERATING ROOM TABLE. DURING INITIAL APPLICATION, THERE WERE NO AIR BUBBLES NOTED. IT IS NOT KNOWN IF THE PATCH BECAME LOOSE PRIOR TO BEING CONNECTED TO THE STOCKERT 70 SYSTEM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. UPON REMOVAL OF THE PATCHES, IT WAS NOTICED THAT THERE WAS BLISTERING AND A BURN BENEATH THE FIRST PATCH AND NO BLISTERS OR BURNS UNDER THE SECOND PATCH. REPAIR FOLLOW-UP WAS PERFORMED AND THE DEVICE WAS NOT SHIPPED FOR SERVICE. SERVICE WAS DECLINED. THEREFORE, WE WERE UNABLE TO CONFIRM THE COMPLAINT. THE DEVICE HISTORY RECORD (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 A PERSISTENT ATRIAL FIBRILLATION PROCEDURE WITH A STOCKERT 70 SYSTEM AND SUSTAINED A SECOND DEGREE BURN BENEATH THE GROUND PATCH ON THE PATIENT'S RIGHT FLANK AREA. THE PATCH HAD BEEN PLACED WHILE ON THE GURNEY BY HOSPITAL STAFF PRIOR TO BEING TRANSFERRED TO THE OPERATING ROOM TABLE. DURING INITIAL APPLICATION, THERE WERE NO AIR BUBBLES NOTED. IT IS NOT KNOWN IF THE PATCH BECAME LOOSE PRIOR TO BEING CONNECTED TO THE STOCKERT 70 SYSTEM. DURING THE PROCEDURE, IMPEDANCE WAS NOTED TO BE IN THE 100-200 OHMS RANGE AND A SECOND PATCH WAS ADDED BY THE LAB TEAM. THE IMPEDANCE CUT OFF WAS NOT EXCEEDED. THERE WAS NO ERROR CODES REPORTED BY THE GENERATOR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. UPON REMOVAL OF THE PATCHES, IT WAS NOTICED THAT THERE WAS BLISTERING AND A BURN BENEATH THE FIRST PATCH AND NO BLISTERS OR BURNS UNDER THE SECOND PATCH. THE PATIENT DID NOT REQUIRE MEDICAL OR SURGICAL INTERVENTION. GENERATOR SETTINGS INCLUDED: POWER CONTROL MODE, IMPEDANCE CUTOFF WAS BELIEVED TO BE SET AT 200 OHMS. OTHER GENERATOR SETTINGS WERE UNKNOWN. THE PHYSICIAN DID NOT PROVIDE AN OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT. IT WAS REPORTED THAT POOR GROUNDING PAD SKIN CONTACT MAY HAVE BEEN THE CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818498 STOCKERT 70 RF GENERATOR RADIOFREQUENCY GENERATOR AND ACCESSORIES/ACCESSORY CABLE DRF STOCKERT GMBH M-5463-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other