MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBLEM S-ICD ELECTRODE DELIVERY SYSTEM; ACCESSORY

Model Number	4712
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	01/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the implant procedure for the subcutaneous implantable cardioverter defibrillator (s-icd) system, the physician believed the tunneling tool may have gotten between the patient's ribs.The physician stopped, pulled back, and evaluated the patient's vitals and took multiple fluoroscopy views.No injury was observed, but the patient complained of soreness in the sternal area after the procedure.The physician believed too steep of an angle was used in an attempt to stay directly on the sternum.The final system placement was excellent and remains in service without further complication.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The tunneling tool entered the thoracic space during the procedure.Please refer to the section b5 for more information regarding the specific circumstances of this event.
Event or Problem Description
It was reported that during the implant procedure for the subcutaneous implantable cardioverter defibrillator (s-icd) system, the physician believed the tunneling tool may have gotten between the patient's ribs.The physician stopped, pulled back, and evaluated the patient's vitals and took multiple fluoroscopy views.No injury was observed, but the patient complained of soreness in the sternal area after the procedure.The physician believed too steep of an angle was used in an attempt to stay directly on the sternum.The final system placement was excellent and remains in service without further complication.No additional adverse patient effects were reported.

• Brand Name: EMBLEM S-ICD ELECTRODE DELIVERY SYSTEM
• Common Device Name: ACCESSORY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16363490
• Report Number: 2124215-2023-06213
• Device Sequence Number: 20518025
• Product Code: LWS
• UDI-Device Identifier: 00802526591907
• UDI-Public: 00802526591907
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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): 03/16/2023

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 Expiration Date: 07/14/2024
• Device Model Number: 4712
• Device Catalogue Number: 4712
• Device Lot Number: 29826960
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2023
• Supplement Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 03/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown