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 04/19/2017

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: unspecified thermocool catheter, unspecified indifferent electrode.This stockert was manufactured before september 24, 2014, therefore no udi is applicable for this product with serial number (b)(4).Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for ischemic left ventricular tachycardia with a stockert 70 system generator and suffered burns second degree requiring an unspecified treatment.Post-procedure, after removing the indifferent electrode, a small skin burn was noticed.Treatment type was unspecified.Stockert generator was set on 30-50 watts.Ablation duration was 60 seconds for each radiofrequency application.There were a total of 25-30 ablation lesions.Multiple attempts have been made to obtain clarification to this complaint.No further information has been made available.No service was requested for the generator.

Manufacturer Narrative

Manufacturer's reference number: (b)(4).It was reported that a patient underwent an ablation procedure for ischemic left ventricular tachycardia with a stockert 70 system generator and suffered burns second degree requiring an unspecified treatment.No service was requested for the generator.As a result, the device was not evaluated, and the customer complaint cannot be confirmed.

• 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: 6557093
• MDR Text Key: 74828818
• Report Number: 9612355-2017-00033
• 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: 04/19/2017

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: 04/19/2017
• Initial Date FDA Received: 05/10/2017
• Supplement Dates Manufacturer Received: 04/19/2017
• Supplement Dates FDA Received: 08/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other