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

Model Number	3200
Medical Device Problem Codes	Defibrillation/Stimulation Problem (1573); Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896)
Health Effect - Clinical Codes	No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient implanted with a subcutaneous implantable cardioverter defibrillator (s-icd) underwent a ventricular tachycardia (vt) ablation procedure.During the procedure, the patient went into ventricular fibrillation (vf).A health care professional (hcp) attempted to deliver a shock through the implanted device by pressing the shock button on this programmer.However, the programmer displayed a message that there were no stored s-ecgs for the patient and shock therapy was not delivered.External rescue was delivered to terminate the rhythm.Further review was performed by a local field representative and determined that the programmer lost telemetry with the s-icd and resulted in the inability to deliver the shock command to the s-icd.This product remains in service.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this patient implanted with a subcutaneous implantable cardioverter defibrillator (s-icd) underwent a ventricular tachycardia (vt) ablation procedure.During the procedure, the patient went into ventricular fibrillation (vf).A health care professional (hcp) attempted to deliver a shock through the implanted device by pressing the shock button on this programmer.However, the programmer displayed a message that there were no stored s-ecgs for the patient and shock therapy was not delivered.External rescue was delivered to terminate the rhythm.Further review was performed by a local field representative and determined that the programmer lost telemetry with the s-icd and resulted in the inability to deliver the shock command to the s-icd.This product remains in service.No additional adverse patient effects were reported.It was reported that the programmer was later returned with no additional information related to the previous reported clinical observations.

• 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 CORPORATION; 229 avenida fabricante; san clemente CA 92672
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 11042762
• Report Number: 2124215-2020-24586
• Device Sequence Number: 11089571
• Product Code: LWS
• UDI-Device Identifier: 00802526586507
• UDI-Public: 00802526586507
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Company Representative
• Initial Reporter Occupation: Physician
• 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: A103876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2020
• Supplement Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 12/19/2020
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown