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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBLEM MRI S-ICD; SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD)
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BOSTON SCIENTIFIC CORPORATION EMBLEM MRI S-ICD; SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) Back to Search Results
Model Number A219
Device Problem Premature Discharge of Battery (1057)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/27/2022
Event Type  Injury  
Event Description
It was reported that there were concerns the subcutaneous implantable cardioverter defibrillator (s-icd) was experiencing premature battery depletion (pbd).Boston scientific technical services (ts) performed a data analysis and found that the device prematurely depleting.Ts recommended the device be replaced within 90 days.The device remains in use.No adverse patient effects were reported.
 
Event Description
It was reported that there were concerns the subcutaneous implantable cardioverter defibrillator (s-icd) was experiencing premature battery depletion (pbd).Boston scientific technical services (ts) performed a data analysis and found that the device prematurely depleting.Ts recommended the device be replaced within 90 days.The device remains in use.No adverse patient effects were reported.Subsequently, the device was explanted and replaced.No additional 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 the subcutaneous implantable cardioverter defibrillator (s-icd) was experiencing premature battery depletion (pbd).Boston scientific technical services (ts) performed a data analysis and found that the device prematurely depleting.Ts recommended the device be replaced within 90 days.The device remains in use.No adverse patient effects were reported.Subsequently, the device was explanted and replaced.No additional adverse patient effects were reported.The device was returned for analysis.
 
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Brand Name
EMBLEM MRI S-ICD
Type of Device
SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD)
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 Key16077561
MDR Text Key308025783
Report Number2124215-2022-55567
Device Sequence Number1
Product Code LWS
UDI-Device Identifier00802526584404
UDI-Public00802526584404
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P110042/S058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 02/17/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date04/04/2019
Device Model NumberA219
Device Catalogue NumberA219
Device Lot Number208958
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/17/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/12/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-0936-2021
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization;
Patient Age66 YR
Patient SexMale
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