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 Problem Partial thickness (Second Degree) Burn (2694)

Event Date 10/04/2016

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 products: thermocool smarttouch sf catheter (model # d-1348-05-s lot # 615506x).This stockert was manufactured before september 24, 2014, therefore, no udi is applicable for this product with serial number (b)(4).(b)(4).

Event Description

It was reported that a male patient, in his mid-60s, underwent an ablation procedure for atrial fibrillation with a stockert 70 rf generator and suffered second degree burns requiring a topical cream and dressing.Post-procedure, a skin burn and blister was observed beneath the valleylab in different electrode that had been positioned on the patient's right lower back.Silvadene cream and a mepilex pad were applied over the affected area.Patient was reported to be in stable condition.Patient did not require extended hospitalization as a result of this event.Patient fully recovered with no residual effects.Physicians opinion regarding the cause of the adverse event is that it was related to patient condition.

Manufacturer Narrative

(b)(4).It was reported that a male patient, in his mid-60s, underwent an ablation procedure for atrial fibrillation with a stockert 70 rf generator and suffered second degree burns requiring a topical cream and dressing.Servicing on the stockert generator was declined.The 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: 6095907
• MDR Text Key: 59785648
• Report Number: 9612355-2016-00061
• 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: 10/20/2016

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: 10/20/2016
• Initial Date FDA Received: 11/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/10/2017
• 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