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

Model Number A209

Device Problems Premature Discharge of Battery (1057); Telemetry Discrepancy (1629)

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

Event Date 03/24/2023

Event Type  Injury  

Manufacturer Narrative

The product is expected to be returned for analysis.This report will be updated upon return and completion of analysis.

Event Description

It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) was implanted in 2016, then the patient moved to another country and did not have device follow ups.The patient had returned and now the s-icd was not able to be interrogated.No tones were produced when a magnet was applied.The device was explanted and replaced.No additional adverse patient effects were reported.The explanted device was planned to be returned for analysis, to determine if the battery depletion was premature and to see if there were any episodes stored.

Manufacturer Narrative

The product is expected to be returned for analysis.This report will be updated upon return and completion of analysis.Upon receipt at our post market quality assurance laboratory, this s-icd was thoroughly inspected and analyzed.A high current drain was detected.Detailed analysis confirmed the identified high current drain was a result of a compromised capacitor.This resulted in the observed premature battery depletion.It was determined that the capacitor was compromised due to the presence of excess hydrogen in the device case.Boston scientific issued a field safety notice regarding a subset of emblem devices that have a potential of exhibiting this behavior.This particular device is included in the emblem s-icd accelerated depletion advisory population.

Event Description

It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) was implanted in 2016, then the patient moved to another country and did not have device follow ups.The patient had returned and now the s-icd was not able to be interrogated.No tones were produced when a magnet was applied.The device was explanted and replaced.No additional adverse patient effects were reported.The explanted device was planned to be returned for analysis, to determine if the battery depletion was premature and to see if there were any episodes stored.

• 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; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16811963
• MDR Text Key: 313985273
• Report Number: 2124215-2023-19938
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: P110042/S043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/16/2018
• Device Model Number: A209
• Device Catalogue Number: A209
• Device Lot Number: 116968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0935-2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female