MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBLEM S-ICD; IMPLANTABLE LEAD

Model Number 3501

Device Problems High impedance (1291); Unexpected Therapeutic Results (1631); Positioning Problem (3009)

Patient Problem Electric Shock (2554)

Event Date 05/12/2023

Event Type  Injury  

Event Description

It was reported that this electrode was a part of a implanted subcutaneous system that had delivered a shock for ventricular tachycardia, which accelerated the arrythmia to ventricular fibrillation, which was then treated with four shocks.The patient was hospitalized and review of device data indicated the shock impedance measurements of the system were high at 130 ohms, however no values were reported to be out of range.An x-ray taken showed the electrode may have originally been implanted in a suboptimal position.Surgical intervention was later performed and the electrode was repositioned and induction testing was successful with two shocks.The electrode remains in service and there have been no additional adverse patient effects reported.

• Brand Name: EMBLEM S-ICD
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17005213
• MDR Text Key: 315992045
• Report Number: 2124215-2023-26353
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P110042/S077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/14/2021
• Device Model Number: 3501
• Device Catalogue Number: 3501
• Device Lot Number: 159712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization