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); Failure to Read Input Signal (1581); Use of Device Problem (1670)

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

Event Date 12/08/2020

Event Type  Injury  

Event Description

It was reported that this device had an alert for a warm boot error via a watchdog reset.The device reset and corrected the error with no impact on therapy.Also, a review of device downloaded memory was done by technical services and premature battery depletion was confirmed.The device remains implanted, however technical services recommended explant.Lastly, the smartpass had turned itself off due to low intrinsic amplitudes.The device sensing vector has now been reprogrammed and smartpass is now back on.There were no adverse patient effects.Boston scientific has issued an advisory communication regarding a subset of subcutaneous implantable cardioverter defibrillators (s-icds) with an elevated rate of early replacement due to hydrogen-induced accelerated battery depletion.This particular device was included in the advisory population.

Event Description

This supplemental report is being filed to provide additional information that this event is included in capa-00006419 emblem sicd transient memory corruption.It was reported that this device had an alert for a warm boot error via a watchdog reset.The device reset and corrected the error with no impact on therapy.Also, a review of device downloaded memory was done by technical services and premature battery depletion was confirmed.The device remains implanted, however technical services recommended explant.Lastly, the smartpass had turned itself off due to low intrinsic amplitudes.The device sensing vector has now been reprogrammed and smartpass is now back on.There were no adverse patient effects.Boston scientific has issued an advisory communication regarding a subset of subcutaneous implantable cardioverter defibrillators (s-icds) with an elevated rate of early replacement due to hydrogen-induced accelerated battery depletion.This particular device was included in the advisory population.

Manufacturer Narrative

This event is included in capa-00006419 emblem sicd transient memory corruption.

Manufacturer Narrative

This event is included in (b)(4) emblem sicd transient memory corruption.The device was explanted (b)(6), 2021.

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 this device had an alert for a warm boot error via a watchdog reset.The device reset and corrected the error with no impact on therapy.Also, a review of device downloaded memory was done by technical services and premature battery depletion was confirmed.The device remains implanted, however technical services recommended explant.Lastly, the smartpass had turned itself off due to low intrinsic amplitudes.The device sensing vector has now been reprogrammed and smartpass is now back on.There were no adverse patient effects.Boston scientific has issued an advisory communication regarding a subset of subcutaneous implantable cardioverter defibrillators (s-icds) with an elevated rate of early replacement due to hydrogen-induced accelerated battery depletion.This particular device was included in the advisory population.(b)(6) 2021 explanted.

Event Description

This supplemental report is being filed to provide additional information regarding product analysis.It was reported that this device had an alert for a warm boot error via a watchdog reset.The device reset and corrected the error with no impact on therapy.Also, a review of device downloaded memory was done by technical services and premature battery depletion was confirmed.The device remains implanted, however technical services recommended explant.Lastly, the smartpass had turned itself off due to low intrinsic amplitudes.The device sensing vector has now been reprogrammed and smartpass is now back on.There were no adverse patient effects.The device was later explanted and replaced.There were no additional adverse patient effects.Boston scientific has issued an advisory communication regarding a subset of subcutaneous implantable cardioverter defibrillators (s-icds) with an elevated rate of early replacement due to hydrogen-induced accelerated battery depletion.This particular device was included in the advisory population.

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.This event is included in capa-00006419 emblem sicd transient memory corruption.The device was explanted (b)(6) 2021.

• 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: 11237797
• MDR Text Key: 228928806
• Report Number: 2124215-2021-02390
• 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: 03/10/2022

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: 02/16/2019
• Device Model Number: A219
• Device Catalogue Number: A219
• Device Lot Number: 206949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2021
• Initial Date FDA Received: 01/27/2021
• Supplement Dates Manufacturer Received: 11/04/2021; 12/09/2021; 01/24/2022
• Supplement Dates FDA Received: 12/19/2021; 12/20/2021; 03/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2017
• 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: 59 YR
• Patient Sex: Male