MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBLEM S-ICD ELECTRODE DELIVERY SYSTEM; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	4712
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	07/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The tunneling tool was not returned for analysis.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
Event or Problem Description
It was reported that a subcutaneous implantable cardioverter defibrillator (s-icd) system was implanted.It was noted the patient had congenital heart disease and underwent a sternotomy in the past, but without wires.The electrode was placed on the right parasternal position.The patient's sternum was observed to be somewhat rotated.The system was implanted using the two-incision technique and automatic setup was performed, with the device picking the secondary vector.However, the device appeared to be sensing the p-waves and the vector was manually changes to primary.Defibrillation threshold (dft) testing was successful and the shock impedance measurement was 46 ohms.Post-implant x-rays were reviewed and the electrode placement almost appeared to be substernal.Two days after the implant, the physician contacted the boston scientific field representative to report a ct scan showed the tip of the electrode was intrathoracic.The patient was stable and there was no adverse effect on the patient.The physician planned a revision procedure for the electrode.The physician noted that during tunneling they did not believe they had a very aggressive angle and also that they could not feel the tunneling tool or electrode once placed.Data and x-rays were reviewed by technical services.The x-ray showed a potential anomaly on the body of the electrode, it appeared to be a kink, and the physician was cautioned to use a new electrode or thoroughly evaluate the existing electrode to ensure there was no actual damage.The electrode revision was performed the following week.The xyphoid incision was reopened and the electrode was pulled out.No damage was observed so the electrode was cleaned for reuse.A new incision was created at the upper sternum and the electrode was re-tunneled from the xyphoid to the upper incision.X-ray showed appropriate position and the incisions were closed.It was noted the physician preferred to maintain the original electrode so the device pocket would not require reopening, to mitigate any risk of infection for this patient.Automatic setup was performed and the device picked the primary vector.Dfts were successful, with a shock impedance measurement of 65 ohms.Data was submitted to technical services, and it was agreed the primary vector exhibited appropriate r-wave amplitudes and r/t ratio.The s-icd system remains implanted and in service.No additional adverse patient effects were reported.

• Brand Name: EMBLEM S-ICD ELECTRODE DELIVERY SYSTEM
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 9270051
• Report Number: 2124215-2019-23004
• Device Sequence Number: 13940910
• Product Code: LWS
• UDI-Device Identifier: 00802526591907
• UDI-Public: 00802526591907
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: P110042/S102
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/02/2019

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: 03/27/2021
• Device Model Number: 4712
• Device Catalogue Number: 4712
• Device Lot Number: 23749220
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2019
• Initial Report FDA Received Date: 11/02/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention