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

Model Number 3501

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Human-Device Interface Problem (2949)

Patient Problems Discomfort (2330); Electric Shock (2554)

Event Date 01/01/2020

Event Type  Injury  

Event Description

It was reported that the patient had an inappropriate shock due to oversensing of noise.The noise could be reproduced during an office visit.The patient recently had an electrode revision procedure due to the electrode protruding.The doctor decided, since the patient's condition is improving, the system was programmed off and remains implanted.There were no additional adverse patient effects.

Event Description

This supplemental report is being filed to provide additional information that the product has been explanted.There were no additional adverse patient effects.It was reported that the patient had an inappropriate shock due to oversensing of noise.The noise could be reproduced during an office visit.The patient recently had an electrode revision procedure due to the electrode protruding.The doctor decided, since the patient's condition is improving, the system was programmed off and remains implanted.There were no additional adverse patient effects.

• Brand Name: EMBLEM S-ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• 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: 16495628
• MDR Text Key: 310794505
• Report Number: 2124215-2023-10611
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526599200
• UDI-Public: 00802526599200
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110042/S077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/19/2020
• Device Model Number: 3501
• Device Catalogue Number: 3501
• Device Lot Number: 151424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/19/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 30 YR
• Patient Sex: Female