MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP MULTIGEN2 RF GENERATOR; GENERATOR, LESION, RADIOFREQUENCY

Catalog Number	8400000000
Medical Device Problem Codes	Energy Output Problem (1431); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Electric Shock (2554)
Date of Event	07/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a rf procedure the patient, who had pacemaker, was shocked.It should be noted that the procedure was completed successfully and there was no medical intervention or surgical delays.
Additional Manufacturer Narrative
Follow-up report submitted to document device evaluation results.
Event or Problem Description
It was reported that during a rf procedure the patient, who had pacemaker, was shocked.It should be noted that the procedure was completed successfully and there was no medical intervention or surgical delays.

• Brand Name: MULTIGEN2 RF GENERATOR
• Common Device Name: GENERATOR, LESION, RADIOFREQUENCY
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 17487797
• Report Number: 3015967359-2023-01797
• Device Sequence Number: 15410652
• Product Code: GXD
• UDI-Device Identifier: 07613327173642
• UDI-Public: 07613327173642
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K170242
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2024

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 Catalogue Number: 8400000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/14/2023
• Supplement Date Received by Manufacturer: 03/20/2024
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown