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

Model Number 3501

Device Problems Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/23/2024

Event Type  Injury  

Event Description

It was reported that the system stored an untreated episode due to oversensing of non-physiological noise.The low energy shock impedance measurement was 95 ohms, which is high but within normal limits.Technical services reviewed and discussed some testing options.The doctor elected to explant the entire system and replace it.There were no additional adverse patient effects.

Manufacturer Narrative

This supplemental report is being filed to provide additional information that the product also had an observation of a lead fracture.There were no additional adverse patient effects.

Event Description

This supplemental report is being filed to provide additional information that the product also had an observation of a lead fracture.There were no additional adverse patient effects.It was reported that the system stored an untreated episode due to oversensing of non-physiological noise.The low energy shock impedance measurement was 95 ohms, which is high but within normal limits.Technical services reviewed and discussed some testing options.There were no adverse patient effects.The system remains implanted.

Event Description

This supplemental report is being filed to provide additional information regarding product analysis.It was reported that the system stored an untreated episode due to oversensing of non-physiological noise.The low energy shock impedance measurement was 95 ohms, which is high but within normal limits.Technical services reviewed and discussed some testing options.The doctor elected to explant the entire system and replace it.There were no additional adverse patient effects.

Manufacturer Narrative

The returned electrode was thoroughly inspected and analyzed.A visual inspection noted surgery related damage consistent with explanations.Resistance tests were completed to assess electrical performance and inner insulation integrity.Measurements throughout these tests were within normal limits.Microscopic inspections of the terminal pin assembly and electrode body found no anomalies.Laboratory analysis did not identify any electrode characteristics that would have caused or contributed to the reported clinical observations.

• 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; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18847738
• MDR Text Key: 337021941
• Report Number: 2124215-2024-13761
• 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,Followup
• Report Date: 05/14/2024

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: 08/02/2020
• Device Model Number: 3501
• Device Catalogue Number: 3501
• Device Lot Number: 125761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2024
• Initial Date FDA Received: 03/06/2024
• Supplement Dates Manufacturer Received: 03/19/2024; 05/14/2024
• Supplement Dates FDA Received: 03/22/2024; 05/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2018
• 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): Hospitalization
• Patient Age: 63 YR
• Patient Sex: Female