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

Model Number A219

Device Problems Premature Discharge of Battery (1057); Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Displays Incorrect Message (2591); Battery Problem (2885)

Patient Problems No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/11/2019

Event Type  Injury  

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited a battery depletion error; however, the error was not representative of actual fast battery depletion and was unintended.Please refer to the description for more information regarding the specific circumstances of this event.

Event Description

It was reported that there was a battery depletion alert via the remote home monitoring system for this subcutaneous implantable cardioverter defibrillator (s-icd).Upon review of the data stored in the device, a boston scientific engineer found that the battery depletion alert was inadvertently triggered due to magnet exposure.It was noted that the alert may be disregarded and the s-icd battery life was within normal parameters.The s-icd remains in service and no adverse patient effects were reported.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited a battery depletion error; however, the error was not representative of actual fast battery depletion and was unintended.Please refer to the description for more information regarding the specific circumstances of this event.

Event Description

It was reported that there was a battery depletion alert via the remote home monitoring system for this subcutaneous implantable cardioverter defibrillator (s-icd).Upon review of the data stored in the device, a boston scientific engineer found that the battery depletion alert was inadvertently triggered due to magnet exposure.It was noted that the alert may be disregarded and the s-icd battery life was within normal parameters.The s-icd remains in service and no adverse patient effects were reported.Additional information was received that the battery of this implantable device was suspected to be depleting prematurely.A request was made to have data from this device analyzed.Data analysis confirmed the battery appeared to be depleting more quickly than expected.Device replacement was recommended.At this time, the device remains in service.No adverse patient effects were reported.

Event Description

This supplemental report is being filed to provide additional information that the product has been explanted and replaced.There were no additional adverse patient effects.It was reported that there was a battery depletion alert via the remote home monitoring system for this subcutaneous implantable cardioverter defibrillator (s-icd).Upon review of the data stored in the device, a boston scientific engineer found that the battery depletion alert was inadvertently triggered due to magnet exposure.It was noted that the alert may be disregarded and the s-icd battery life was within normal parameters.The s-icd remains in service and no adverse patient effects were reported.Additional information was received that the battery of this implantable device was suspected to be depleting prematurely.A request was made to have data from this device analyzed.Data analysis confirmed the battery appeared to be depleting more quickly than expected.Device replacement was recommended.At this time, the device remains in service.No adverse patient effects were reported.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited a battery depletion error; however, the error was not representative of actual fast battery depletion and was unintended.Please refer to the description for more information regarding the specific circumstances of this event.

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 an advisory communication in august 2019 regarding a subset of emblem devices that has an elevated potential of exhibiting this behavior; the population of devices that may be impacted was expanded in december 2020.This particular device is included in the emblem s-icd accelerated depletion advisory population.

Event Description

This supplemental report is being filed to provide additional information regarding product analysis.This supplemental report is being filed to provide additional information that the product has been explanted and replaced.There were no additional adverse patient effects.It was reported that there was a battery depletion alert via the remote home monitoring system for this subcutaneous implantable cardioverter defibrillator (s-icd).Upon review of the data stored in the device, a boston scientific engineer found that the battery depletion alert was inadvertently triggered due to magnet exposure.It was noted that the alert may be disregarded and the s-icd battery life was within normal parameters.The s-icd remains in service and no adverse patient effects were reported.Additional information was received that the battery of this implantable device was suspected to be depleting prematurely.A request was made to have data from this device analyzed.Data analysis confirmed the battery appeared to be depleting more quickly than expected.Device replacement was recommended.At this time, the device remains in service.No adverse patient effects were reported.

• Brand Name: EMBLEM MRI 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: 9547697
• MDR Text Key: 174094817
• Report Number: 2124215-2019-27314
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526584404
• UDI-Public: 00802526584404
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110042/S058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/26/2022

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: 11/22/2019
• Device Model Number: A219
• Device Catalogue Number: A219
• Device Lot Number: 219113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2019
• Initial Date FDA Received: 01/03/2020
• Supplement Dates Manufacturer Received: 06/02/2022; 08/02/2022; 09/26/2022
• Supplement Dates FDA Received: 06/18/2022; 08/08/2022; 09/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2017
• 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): Hospitalization
• Patient Age: 14 YR
• Patient Sex: Male