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

Model Number	PS100-102
Medical Device Problem Code	Electromagnetic Interference (1194)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a manufacture representative (rep) regarding a generator and a hand piece being used for a pacemaker change.It was reported that during the procedure, there was an interference with icd.The site changed the handpiece to surgical knife and the handpiece was discarded after the surgery.The cause or potential contributing factors of the event were not determined.

• Brand Name: PULSAR II GENERATOR
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEDTRONIC ADVANCED ENERGY (SALIENT); 180 international drive; portsmouth NH 03801
• MDR Report Key: 10555429
• Report Number: 1226420-2020-00111
• Device Sequence Number: 17028935
• Product Code: GEI
• UDI-Device Identifier: 00643169467354
• UDI-Public: 00643169467354
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K102029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PS100-102
• Device Catalogue Number: PS100-102
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2020
• Initial Report FDA Received Date: 09/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1