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

Model Number A209

Device Problems Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Anxiety (2328); Discomfort (2330); Electric Shock (2554)

Event Date 10/01/2020

Event Type  Injury  

Event Description

It was reported that the patient implanted with this subcutaneous implantable cardioverter defibrillator (s-icd) system received inappropriate shocks due to oversensing.Which led to the patient experiencing anxiety.A revision procedure was performed and the s-icd system was explanted.No additional adverse patient effects were reported.

Event Description

It was reported that the patient implanted with this subcutaneous implantable cardioverter defibrillator (s-icd) system received inappropriate shocks due to oversensing.Which led to the patient experiencing anxiety and discomfort.A revision procedure was performed and the s-icd system was explanted.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, analysis of the returned device found no evidence of device defect, malfunction, or damage outside the bounds of normal medical use.The device was subjected to and passed all automated testing.Laboratory analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.

Event Description

It was reported that the patient implanted with this subcutaneous implantable cardioverter defibrillator (s-icd) system received inappropriate shocks due to oversensing.Which led to the patient experiencing anxiety and discomfort.A revision procedure was performed and the s-icd system was explanted.No additional adverse patient effects were reported.

• Brand Name: EMBLEM S-ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16565671
• MDR Text Key: 311504084
• Report Number: 2124215-2023-12787
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526544101
• UDI-Public: 00802526544101
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110042/S043
• 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,Followup
• Report Date: 11/08/2023

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/27/2017
• Device Model Number: A209
• Device Catalogue Number: A209
• Device Lot Number: 103423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2023
• Initial Date FDA Received: 03/17/2023
• Supplement Dates Manufacturer Received: 06/02/2023; 10/23/2023
• Supplement Dates FDA Received: 06/19/2023; 11/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female