MAUDE Adverse Event Report: MEDTRONIC ADVANCED ENERGY (SALIENT) UNKNOWN MAE DEVICE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number MAE UNK DEV

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tachycardia (2095)

Event Date 02/16/2021

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 a manufacture representative (rep) regarding a generator and a handpiece.It was reported that during a case, the pacemaker was being replaced due to standard replacement timing.The plasma blade was used to dissect pocket, an arrhythmia occurred during plasma blade use, the hospital wonder if this was caused by transmission of energy along the pacing lead or ront caused by noise reversion mode of the pacemaker.The patient was in sinus rhythm prior to application of cautery.No further patient complications have been reported as a result of this event.

• Brand Name: UNKNOWN MAE DEVICE
• 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: 11436216
• MDR Text Key: 238370874
• Report Number: 1226420-2021-00057
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: 704268499
• 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: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MAE UNK DEV
• Device Catalogue Number: MAE UNK DEV
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening