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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 Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Failure to Read Input Signal (1581)
Patient Problems Hematoma (1884); Electric Shock (2554)
Event Date 05/21/2023
Event Type  Injury  
Event Description
It was reported that the recently implanted subcutaneous implantable cardioverter defibrillator (s-icd) delivered an inappropriate shock due to t-wave oversensing.The patient had developed a hematoma while receiving coumadin and it was suspected that the hematoma had affected the r-wave and t-wave ratio.The s-icd was turned off, pending follow-up.The patient also had a dual chamber pacemaker system implanted (non-boston scientific product) and technical services recommended attempting to pace the patient ddd at an increased rate to evaluate the appropriate s-icd programming vector for the patient.
 
Manufacturer Narrative
Please see correction to section f.Additional device code: a1301.
 
Event Description
It was reported that the recently implanted subcutaneous implantable cardioverter defibrillator (s-icd) delivered an inappropriate shock due to t-wave oversensing.The patient had developed a hematoma while receiving coumadin and it was suspected that the hematoma had affected the r-wave and t-wave ratio.The s-icd was turned off, pending follow-up.The patient also had a dual chamber pacemaker system implanted (non-boston scientific product) and technical services recommended attempting to pace the patient ddd at an increased rate to evaluate the appropriate s-icd programming vector for the patient.
 
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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 degroot
4100 hamline avenue north
saint paul, MN 55112
6515826168
MDR Report Key17026163
MDR Text Key316193204
Report Number2124215-2023-27320
Device Sequence Number1
Product Code LWS
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/24/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/30/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberA219
Device Catalogue NumberA219
Device Lot Number179215
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/27/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/10/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age23 YR
Patient SexMale
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