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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBLEM MRI S-ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
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BOSTON SCIENTIFIC CORPORATION EMBLEM MRI S-ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) Back to Search Results
Model Number A219
Device Problems Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438); Failure to Convert Rhythm (1540); Under-Sensing (1661); Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/17/2023
Event Type  Injury  
Event Description
It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) system exhibited high out of range shock impedance measurements as the electrode had not been fully inserted into the header of the device.Surgical intervention was performed and the electrode was re-inserted into the header and induction testing was performed.During testing, undersensing was observed thus making it difficult to convert the patient with shocks from the system.An external shock was eventually able to convert the patient successfully.The s-icd remains in service and there were no additional adverse patient effects reported.
 
Event Description
It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) system exhibited high out of range shock impedance measurements as the electrode had not been fully inserted into the header of the device.Surgical intervention was performed and the electrode was re-inserted into the header and induction testing was performed.During testing, undersensing was observed thus making it difficult to convert the patient with shocks from the system.An external shock was eventually able to convert the patient successfully.The s-icd remains in service and there were no additional adverse patient effects reported.
 
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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 Key16763470
MDR Text Key313521060
Report Number2124215-2023-18288
Device Sequence Number1
Product Code LWS
UDI-Device Identifier00802526584404
UDI-Public00802526584404
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P110042/S058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/26/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date12/02/2023
Device Model NumberA219
Device Catalogue NumberA219
Device Lot Number154630
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/25/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/10/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age33 YR
Patient SexMale
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