MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CARDIAC STIMULATOR; GENERATOR, PULSE, PACEMAKER, EXTERNAL PROGRAMMABLE

Model Number	86650
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during pulse field ablation (pfa) procedure using a micropace stimulator pacing becomes unavailable after energization.During the procedure there is an issue with the micro pace and stimulation capabilities become unavailable during the procedure, there was no back up pacing in place for emergency situations.No procedure in progress has been cancelled and there have been no patient complications.It is not known if the system will be returned for analysis as it is to be serviced on site.
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that during pulse field ablation (pfa) procedure using a micropace stimulator pacing becomes unavailable after energization.During the procedure there is an issue with the micro pace and stimulation capabilities become unavailable during the procedure, there was no back up pacing in place for emergency situations.No procedure in progress has been cancelled and there have been no patient complications.The machine was serviced on site.
Additional Manufacturer Narrative
Although the device was not returned, a field service assessment was performed to examine the micropace cardiac stimulator.The field service engineer reported that no problems were found with the micropace cardiac stimulator during the assessment.Additionally, the field service engineer replaced the farastar generator's printed circuit board assembly (pcba) relay, which serves as a switch to open/close the circuit during pfa energy delivery and no further interference between the farastar generator and the micropace cardiac stimulator has been observed.The micropace cardiac stimulator remains in service at the healthcare facility.Based on the available information, boston scientific's investigation concluded there was no problem detected with the micropace generator as it passed all functional and safety testing at the facility.The cause of the incident was the farastar generator's pcba relay which was replaced at the healthcare facility and resolved the interference between the farastar generator and micropace cardiac stimulator.E1: initial reporter phone: (b)(6).

• Brand Name: CARDIAC STIMULATOR
• Common Device Name: GENERATOR, PULSE, PACEMAKER, EXTERNAL PROGRAMMABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): MICROPACE PTY LTD; 41 159 arthur street; homebush west, nsw 2140 ; AS 2140
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 21053590
• Report Number: 2124215-2024-82776
• Device Sequence Number: 20820128
• Product Code: JOQ
• UDI-Device Identifier: 09349714001721
• UDI-Public: (01)09349714001721(11)220503(10)22-256
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2025

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: 86650
• Device Catalogue Number: 86650
• Device Lot Number: 22-256
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2024
• Supplement Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 06/13/2025
• Date Device Manufactured: 05/03/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FARASTAR PULSE FIELD ABLATION GENERATOR.; FARASTAR PULSE FIELD ABLATION GENERATOR.
• Patient Sex: Unknown