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

Model Number M-5463-01

Device Problem Insufficient Information (3190)

Patient Problems Swelling (2091); Diaphoresis (2452); Partial thickness (Second Degree) Burn (2694)

Event Date 01/07/2014

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: (b)(4).It was reported during an atrioventricular nodal reentrant tachycardia (avnrt) procedure, the patient had a burn on the left leg where the grounding pad was attached.The degree of the burn was unknown.It was unknown if treatment was performed.The status of the patient was fine.Additional clarification on the event was requested but had not been received.Additional information was provided on the event.It was reported after the procedure that a skin blister was noticed where the impedance patch was placed.The patient was very obese and diaphoretic and was thought to contribute to the patch not in good contact.It was a second degree burn.A skin graft was performed.The event required extended hospitalization of extra days, but the patient fully recovered.The patient will not require further treatment.The event was not life threatening.The prognosis for the patient is satisfactory.The patients updated health status is good.The generator settings were 50 watts/60 degrees.Total ablation procedure duration was four hours.The duration per ablation was 30 seconds minimum and 120 seconds maximum.It was informed that this is a non bwi related issue.The customer does not want the system tested.The device history record (dhr) 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.

Event Description

It was reported during an atrioventricular nodal reentrant tachycardia (avnrt) procedure, the patient had a burn on the left leg where the grounding pad was attached.The degree of the burn was unknown.It was unknown if treatment was performed.The status of the patient was fine.Additional clarification on the event was requested but had not been received.With the information available stating that the patient was fine and the lack of information regarding the degree of burn and the need for medical intervention, the event was not considered a serious injury and was not reportable.On (b)(6) 2014, additional information was provided on the event.It was reported after the procedure that a skin blister was noticed where the impedance patch was placed.The patient was very obese and diaphoretic and was thought to contribute to the patch not in good contact.It was a second degree burn.A skin graft was performed.The event required extended hospitalization of extra days, but the patient fully recovered.The patient will not require further treatment.The event was not life threatening.The prognosis for the patient is satisfactory.The patient return electrode was valleylab.The serial number was unknown.The size of the indifferent electrode was 8x8.The location of the indifferent electrode was on the left flank.The condition being treated was a flutter.The patients updated health status is good.The generator settings were 50 watts/60 degrees.Total ablation procedure duration was four hours.The duration per ablation was 30 seconds minimum and 120 seconds maximum.The second degree burn is indicative of a reportable event, thus marking january 22, 2014 as the awareness date for this event.

Manufacturer Narrative

Investigation still in progress.A supplemental report or device evaluation will be submitted.Concomitant products: carto 3 system: model #:m-4800-01, serial #:(b)(4).A fj decapolar catheter: model: unknown, lot #: unknown.Distributed - acunav catheter: model #: unknown, lot #: unknown.4 mm navigation ablation catheter: model #:unknown, lot #: unknown.Non bwi - st.Jude medical cournand catheter.(b)(4).

• 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-79 111; GM D-79111
• Manufacturer Contact: jaime chavez ; 15715 arrow hwy; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 3600862
• MDR Text Key: 11656174
• Report Number: 9612355-2014-00006
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/08/2014

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: 01/08/2014
• Initial Date FDA Received: 01/30/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention