MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBLEM MRI S-ICD; IMPLANTABLE DEVICE

Model Number A219

Device Problems Premature Discharge of Battery (1057); Data Problem (3196)

Patient Problems Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/22/2022

Event Type  Injury  

Event Description

It was reported that the battery of this subcutaneous implantable cardioverter defibrillator (s-icd) 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.There were also a large number of episodes stored on the s-icd, and it was thought the patient may have had radiation therapy for their bladder cancer that may have affected the device.Furthermore, it was noted the s-icd experienced memory corruption affecting device counters, which could also be caused by ionizing radiation.It was noted that despite the memory corruption, the s-icd appeared to be functioning normally.No adverse patient effects were reported.

Event Description

It was reported that the battery of this subcutaneous implantable cardioverter defibrillator (s-icd) 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.There were also a large number of episodes stored on the s-icd, and it was thought the patient may have had radiation therapy for their bladder cancer that may have affected the device.Furthermore, it was noted the s-icd experienced memory corruption affecting device counters, which could also be caused by ionizing radiation.It was noted that despite the memory corruption, the s-icd appeared to be functioning normally.No adverse patient effects were reported.Additional information was received indicating the s-icd system was explanted and replaced with a transvenous implantable cardioverter defibrillator (icd) system.It was noted that the s-icd had caused chronic pain at the s-icd site.No additional adverse patient effects were reported.

Manufacturer Narrative

Device memory analysis identified an error.The error resulted in software resets performed in an attempt to correct an identified memory inconsistency.The cause of the memory inconsistency was not able to be determined but was likely the result of a single event upset caused by high energy particles in the environment.Technical services advised the patient should be seen so that the patient data could be reset, but that critical therapy remained available.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.

Manufacturer Narrative

Device memory analysis identified an error.The error resulted in software resets performed in an attempt to correct an identified memory inconsistency.The cause of the memory inconsistency was not able to be determined but was likely the result of a single event upset caused by high energy particles in the environment.Technical services advised the patient should be seen so that the patient data could be reset, but that critical therapy remained available.

Event Description

It was reported that the battery of this subcutaneous implantable cardioverter defibrillator (s-icd) 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.There were also a large number of episodes stored on the s-icd, and it was thought the patient may have had radiation therapy for their bladder cancer that may have affected the device.Furthermore, it was noted the s-icd experienced memory corruption affecting device counters, which could also be caused by ionizing radiation.It was noted that despite the memory corruption, the s-icd appeared to be functioning normally.No adverse patient effects were reported.Additional information was received indicating the s-icd system was explanted and replaced with a transvenous implantable cardioverter defibrillator (icd) system.It was noted that the s-icd had caused chronic pain at the s-icd site.No additional adverse patient effects were reported.

• Brand Name: EMBLEM MRI S-ICD
• Type of Device: IMPLANTABLE DEVICE
• 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: 16756131
• MDR Text Key: 313484973
• Report Number: 2124215-2023-18091
• 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: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 07/24/2023

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: 02/13/2020
• Device Model Number: A219
• Device Catalogue Number: A219
• Device Lot Number: 223291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2023
• Initial Date FDA Received: 04/17/2023
• Supplement Dates Manufacturer Received: 05/11/2023; 07/20/2023
• Supplement Dates FDA Received: 05/30/2023; 07/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2018
• 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; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male