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

Model Number M-5463-01

Device Problems Failure To Adhere Or Bond (1031); Malposition of Device (2616); Positioning Problem (3009)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 01/09/2017

Event Type  Injury  

Manufacturer Narrative

Not in complete contact with the patient¿s back due to the issues related to the patient¿s large body habitus.There is no information regarding if there were any air pockets present between the skin and the indifferent electrode, if conductive gel was present on the indifferent electrode, if the indifferent electrode was moist, or if the indifferent electrode used with the stockert 70 system generator was at least = 124 cm2.There were no error codes reported by the stockert 70 system generator.There we no impedance errors or alerts at baseline or during ablation.Since this adverse event required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr reportable.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.This stockert was manufactured before september 24, 2014, therefore no udi is applicable for this product with serial number (b)(4).Concomitant products: carto 3 system: model #: m-4800-01, serial #: (b)(4).Smart touch bidirectional sf catheter: model #: d-1348-05.Non biosense webster, inc.- covidien indifferent electrode patch.(b)(4).

Event Description

It was reported that a male patient underwent an ablation procedure for drug refractory persistent atrial fibrillation with a stockert 70 system generator and suffered burns second degree requiring wound care.Post-procedure, the patient was noted to have a large skin burn (dimensions unspecified) on the lower back under the indifferent electrode.Wound care was administered.The patient required extended hospitalization as the patient was unable to tend to the wound on his back.It was noted that it is unknown if a biosense webster, inc.Product was responsible for the injury.Physician¿s opinion regarding the cause of the adverse event include that the grounding pad (indifferent electrode) was not fully adhered to a flat surface on the skin secondary to issues related to the patient¿s large body habitus and the inability of the stockert 70 system generator to indicate the percentage of skin contact with the grounding pad.Generator settings included power at 25-35 watts, with average of 30-35 watts throughout the 4 hour procedure.There is no information regarding if the patient contact area and the indifferent electrode were properly prepared per the indifferent electrode instructions for use.Indifferent electrode was not positioned at a location on the back as close to the heart as possible.The indifferent electrode was placed at the patient¿s lower back.It was assumed that the entire surface area of the grounding pad was.

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).It was reported that a male patient underwent an ablation procedure for drug refractory persistent atrial fibrillation with a stockert 70 system generator.Post-procedure, the patient was noted to have a large skin burn (dimensions unspecified) on the lower back under the indifferent electrode.Wound care was administered.The patient required extended hospitalization as the patient was unable to tend to the wound on his back repair follow-up was performed and the device was not shipped for service.Service was declined.Complaint was unable to be confirmed.The device history record (dhr) 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: 6294855
• MDR Text Key: 66328371
• Report Number: 9612355-2017-00004
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/10/2017

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: 01/10/2017
• Initial Date FDA Received: 02/01/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 218