MAUDE Adverse Event Report: STOCKERT GMBH STOCKERT 70 RF GENERATOR; RADIOFREQUENCY GENERATOR AND ACCESSORIES/ACCESSORY CABLE

Model Number M-5463-01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pneumonia (2011); Scarring (2061); Full thickness (Third Degree) Burn (2696)

Event Date 10/11/2016

Event Type  Injury  

Manufacturer Narrative

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 medical products: carto 3 system (model# unknown serial# unknown).This stockert was manufactured before september 24, 2014, therefore no udi is applicable for this product with serial number (b)(4).(b)(4) are related to the same incident.Generator settings include impedance between 50 to 250 ohms, power settings unknown, the total ablation procedure duration is unknown and the duration per ablation was less than 60 seconds.There were no error codes reported by the stockert generator.

Event Description

It was reported that a patient, (b)(6), female, underwent an atrioventricular node ablation procedure with a stockert 70 rf generator and suffered third degree skin burn and pneumonia.The patient had a history of multiple issues including, congestive heart failure and chronic prednisone therapy.The patient returned to the hospital after a recent ablation with pneumonia.It was also noted that a 4cm skin burn was seen where the indifferent electrode was placed during ablation, using a stockert generator.The patient was treated at first with silvadene cream then dressings with medihoney calcium alginate wound dressing and sent home.The patient was then readmitted for pneumonia and had surgery for the burn in question.The wound was debrided and closed.The patient did not require extended hospitalization.Permanent damage was done as the patient had a scar on her back from the skin burn.The physician¿s opinion on the cause of the adverse events was the patient had multiple problems going on and has been in and out of the hospital all year.A covidien e7506 valley lab non-rem polyhesive patient return electrode indifferent electrode patch was used during the procedure.The patient contact area and the indifferent electrode were properly prepared per the indifferent electrode instructions for use.Upon opening the package for the grounding pad, the conductive gel was present on the indifferent electrode and it was moist.The indifferent electrode was positioned at a location on the back as close to the heart as possible as it was placed on the patient¿s right mid back.The entire surface area of the grounding pad was in complete contact with the patients back.It was not noted if there were any air pockets present between the skin and the indifferent electrode.The indifferent electrode used with the stockert generator at least greater than 124 cm2.

Manufacturer Narrative

Manufacturer's ref.No: (b)(4) it was reported that a patient, (b)(6), female, underwent an atrioventricular node ablation procedure with a stockert 70 rf generator and suffered third degree skin burn and pneumonia.Repair follow-up was performed and device was not shipped for service.Service was declined.Complaint was unable to be confirmed.The device history record review verifies that the device was manufactured in accordance with documented specification and procedures.

• Brand Name: STOCKERT 70 RF GENERATOR
• Type of Device: RADIOFREQUENCY GENERATOR AND ACCESSORIES/ACCESSORY CABLE
• Manufacturer (Section D): STOCKERT GMBH; boetzinger strasse 72; freiburg, b-w D-791 11; GM D-79111
• Manufacturer (Section G): STOCKERT GMBH; boetzinger strasse 72; freiburg, b-w D-791 11; GM D-79111
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6119483
• MDR Text Key: 60629208
• Report Number: 9612355-2016-00065
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• PMA/PMN Number: P990071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M-5463-01
• Device Catalogue Number: S7001
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/25/2016
• Initial Date FDA Received: 11/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 64 YR
• Patient Weight: 65