BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STOCKERT 70 RF GENERATOR

    MDR report key: 3844679 · Received June 3, 2014

    Report

    Report Number
    9612355-2014-00027
    Event Type
    Injury
    Date Received
    June 3, 2014
    Date of Event
    March 27, 2014
    Report Date
    May 12, 2014
    Manufacturer
    STOCKERT GMBH
    Product Code
    DRF
    PMA / PMN Number
    P990071
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    REFER TO EVALUATION SUMMARY: (B)(4). IT WAS REPORTED FROM FDA THAT A PATIENT WAS DISCOVERED TO HAVE SUSTAINED A SEVERE FULL THICKNESS SKIN BURN PENETRATING INTO SUBCUTANEOUS FAT AT THE SITE OF THE GROUNDING PAD. FOLLOW UP WAS PERFORMED AND NO INFORMATION WAS PROVIDED TO BIOSENSE WEBSTER. NO MALFUNCTION OF DEVICE WAS REPORTED.

    Description of Event or Problem · 1

    ON (B)(4) 2014, BIOSENSE WEBSTER RECEIVED THE MEDWATCH FORM FROM FDA WHICH WAS STATED: AN ABLATION OF TYPICAL ATRIAL FLUTTER WAS PERFORMED USING THE BIOSENSEWEBSTER FLUTTER 8MM CATHETER, STOCKERT 70 RF GENERATOR, AND COVIDIEN GROUNDING PAD; IMPEDANCE CHARACTERISTICS AND FEEDBACK DATA FROM THE CATHETER WERE UNREMARKABLE DURING THE PROCEDURE. FOLLOWING THE CONCLUSION OF THE PROCEDURE, THE PATIENT WAS DISCOVERED TO HAVE SUSTAINED A SEVERE FULL THICKNESS SKIN BURN PENETRATING INTO SUBCUTANEOUS FAT AT THE SITE OF THE GROUNDING PAD. ALARM BEHAVIOR AND CONNECTION TO THE GROUNDING PAD WERE UNREMARKABLE DURING THE PROCEDURE. THERE IS NO AVAILABLE INFORMATION REGARDING THE PATIENT OR THE LOCATION OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325005 STOCKERT 70 RF GENERATOR RADIOFREQUENCY GENERATOR AND ACCESSORIES/ACCESSORY CABLE DRF STOCKERT GMBH M-5463-01

    Patients

    Seq Age Sex Outcome Treatment
    1