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); Battery Problem (2885)

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

Event Date 05/23/2023

Event Type  Injury  

Event Description

It was reported that this subcutaneous implantable defibrillator (s-icd) device battery showed an unexpected decrease of 5% in remaining longevity within two months.Technical services was contacted for a data review and it was confirmed the battery was depleting prematurely.It was recommended that the device should be replaced within 90 days.At this time, the s-icd remains implanted and in-service.The patient was stable with no adverse effects reported.

Event Description

It was reported that this subcutaneous implantable defibrillator (s-icd) device battery showed an unexpected decrease of 5% in remaining longevity within two months.Technical services was contacted for a data review and it was confirmed the battery was depleting prematurely.It was recommended that the device should be replaced within 90 days.The s-icd was subsequently explanted and replaced to resolve the event.The patient was stable with no additional adverse effects reported.The device is expected to be returned for analysis, but has not yet been received.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, this s-icd was thoroughly inspected and analyzed.A high current drain was detected, but the battery still supported full device function.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 defibrillator (s-icd) device battery showed an unexpected decrease of 5% in remaining longevity within two months.Technical services was contacted for a data review and it was confirmed the battery was depleting prematurely.It was recommended that the device should be replaced within 90 days.The s-icd was subsequently explanted and replaced to resolve the event.The patient was stable with no additional adverse effects reported.The device has been received for analysis.

• 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: 17035561
• MDR Text Key: 316298581
• Report Number: 2124215-2023-27729
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P110042/S043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/13/2017
• Device Model Number: A209
• Device Catalogue Number: A209
• Device Lot Number: 103957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0935-2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention