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

Model Number A219

Device Problems Premature Discharge of Battery (1057); Incorrect, Inadequate or Imprecise Result or Readings (1535); Noise, Audible (3273)

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

Event Date 04/11/2023

Event Type  Injury  

Event Description

It was reported that there were concerns of premature battery depletion for this subcutaneous implantable cardioverter defibrillator.The device displayed a battery depletion fault code and beeping tones were heard.A request was made to have data from this device analyzed.The data analysis noted the battery appeared to be depleting more quickly than expected.A device replacement was recommended.The device remains in service and there is no evidence to suggest a device replacement procedure has been scheduled at this time.No adverse patient effects were reported.

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 there were concerns of premature battery depletion for this subcutaneous implantable cardioverter defibrillator.The device displayed a battery depletion fault code and beeping tones were heard.A request was made to have data from this device analyzed.The data analysis noted the battery appeared to be depleting more quickly than expected.A device replacement was recommended.Subsequently this device was explanted and successfully replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

The product has been received for analysis.Upon completion of the analysis of the complaint device, if there is any further relevant information from the review, a supplemental report will be filed.

Event Description

It was reported that there were concerns of premature battery depletion for this subcutaneous implantable cardioverter defibrillator.The device displayed a battery depletion fault code and beeping tones were heard.A request was made to have data from this device analyzed.The data analysis noted the battery appeared to be depleting more quickly than expected.A device replacement was recommended.Subsequently this device was explanted and successfully replaced.No additional adverse patient effects were reported.

• Brand Name: EMBLEM MRI S-ICD
• Type of Device: SUBCUTANEOUS 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: 16817093
• MDR Text Key: 314038484
• Report Number: 2124215-2023-20115
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P110042/S058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/23/2019
• Device Model Number: A219
• Device Catalogue Number: A219
• Device Lot Number: 209854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0936-2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Male