MAUDE Adverse Event Report: PLEXUS EMBLEM S-ICD PROGRAMMER; EXTERNAL PROGRAMMER

Model Number	3200
Medical Device Problem Codes	Use of Device Problem (1670); Application Program Problem (2880); Interrogation Problem (4017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this programmer could not interrogate the pulse generator.The programmer had an error message.Technical services suspects this is due to the programmer having older software than the device.A local representative will be contacted to get the latest software.There were no adverse patient effects.The device remains implanted.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this programmer was thoroughly inspected and analyzed.The programmer was able to boot up and load boston scientific software.The software version was at level 4.08.The software version 4.09 was applied to the returned programmer.The programmer was able to interrogate a pulse generator and it updated it to the newest firmware.It was concluded that the red screen observed in the field was likely caused by a mismatch between the programmer's software and the implantable device firmware.
Event or Problem Description
This supplemental report is being filed to provide additional information regarding programmer analysis.It was reported that this programmer could not interrogate the pulse generator.The programmer had an error message.Technical services suspects this is due to the programmer having older software than the device.A local representative will be contacted to get the latest software.There were no adverse patient effects.The device remains implanted.The programmer was later returned.

• Brand Name: EMBLEM S-ICD PROGRAMMER
• Common Device Name: EXTERNAL PROGRAMMER
• Manufacturer (Section D): PLEXUS; 2400 millbrook dr; buffalo grove IL 60089
• Manufacturer (Section G): BOSTON SCIENTIFIC INC
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 14628505
• Report Number: 2124215-2022-20035
• Device Sequence Number: 6113728
• Product Code: LWS
• UDI-Device Identifier: 00802526586507
• UDI-Public: 00802526586507
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P110042/S009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2022

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
• Operator of Device: Health Professional
• Device Model Number: 3200
• Device Catalogue Number: 3200
• Device Lot Number: 2000355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/01/2022
• Supplement Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 06/29/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown