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

Model Number	3200
Medical Device Problem Codes	Failure to Power Up (1476); Defibrillation/Stimulation Problem (1573); Data Problem (3196); Noise, Audible (3273)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during sicd implant procedure the patient was induced but the programmer screen froze up and the field representative attempted to shut down the programmer.Medical intervention was required to convert the patient.An additional induction test was performed afterwards and was successful.After the procedure the programmer would not power on even after troubleshooting.Follow up indicated that the programmer began to beep tones when attempting to ship the device.No additional intervention was required.
Additional Manufacturer Narrative
Upon receipt, the programmer underwent functional testing.The programmer was attempted to be powered on, however was unable to due to low battery status.After the battery was fully charged the programmer exhibited a screen prompting for reset.All log and session files were corrupted and unable to be loaded.The programmer was opened in order to assess the internal components.Detailed inspection identified an internal electrical component that caused intermittent communication resulting in the reported clinical observations.
Event or Problem Description
This supplemental report is being filled to include device analysis information.

• Brand Name: EMBLEM S-ICD PROGRAMMER
• Common Device Name: EXTERNAL PROGRAMMER
• Manufacturer (Section D): PLEXUS; 2400 millbrook dr; buffalo grove IL 60089
• MDR Report Key: 10027211
• Report Number: 2124215-2020-10163
• Device Sequence Number: 11602319
• Product Code: LWS
• UDI-Device Identifier: 00802526586507
• UDI-Public: 00802526586507
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P110042/S009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2020

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: A104620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• Initial Date Received by Manufacturer: 03/19/2020
• Supplement Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 05/05/2020
• Supplement Report FDA Received Date: 07/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention