MAUDE Adverse Event Report: MEDTRONIC ADVANCED ENERGY (SALIENT) AEX GENERATOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number 40-405-1

Device Problem Arcing of Electrodes (2289)

Patient Problems Numbness (2415); Electric Shock (2554)

Event Date 03/11/2021

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via manufacture representative (rep) regarding a generator and a handpiece.It was reported that during a battery replacement, the patient experienced one big electrical shock that went to the opposite right arm and hand and also to upper leg and lower leg.Not the foot at all.It was noted that the patient did feel numbness in the right arm and leg for 5 minutes.It went away after 10 minutes totally.It was further stated that the handpiece tip did touch accidently the implantable neurostimulator when the neurosurgeon was dissecting in the upper part of the pocket.The neurosurgeon did stop to use the generator and the handpiece immediately.The doctor did measure post-operative electrode impedance and therapy impedance.They were all with in the same range as before the battery replacement.There was no reported impact to patient outcome.

• Brand Name: AEX GENERATOR
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEDTRONIC ADVANCED ENERGY (SALIENT); 180 international drive; portsmouth NH 03801
• Manufacturer (Section G): MEDTRONIC ADVANCED ENERGY (SALIENT); 180 international drive; portsmouth NH 03801
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11563581
• MDR Text Key: 242066536
• Report Number: 1226420-2021-00069
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K143175
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/24/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 40-405-1
• Device Catalogue Number: 40-405-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2021
• Initial Date FDA Received: 03/24/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/16/2020
• 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): Other