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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 Problem Electric Shock (2554)
Event Date 05/20/2023
Event Type  malfunction  
Manufacturer Narrative
No additional information is available.If additional information becomes available the report will be updated at that time.
 
Event Description
It was reported that the patient received an inappropriate shock from the subcutaneous implantable cardioverter defibrillator (s-icd) following deactivation of smartpass.The patient was noted to also have a leadless pacemaker implanted.Technical services (ts) was consulted to discuss reasons for smartpass deactivation.Ts discussed the possible reasons that smartpass may automatically deactivate.The field representative would discuss this with the physician.At the time the serial number of the s-icd was unknown.Attempts to obtain this information are being made.
 
Manufacturer Narrative
No additional information is available.If additional information becomes available the report will be updated at that time.
 
Event Description
It was reported that the patient received an inappropriate shock from the subcutaneous implantable cardioverter defibrillator (s-icd) following deactivation of smartpass.The patient was noted to also have a leadless pacemaker implanted.Technical services (ts) was consulted to discuss reasons for smartpass deactivation.Ts discussed the possible reasons that smartpass may automatically deactivate.The field representative would discuss this with the physician.At the time the serial number of the s-icd was unknown.Attempts to obtain this information are being made.Additional information was received that the cause of the inappropriate shock was due to t-wave oversensing and sensing optimization was performed.The field representative noted that the serial number of the device was unable to be obtained.
 
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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
Manufacturer Contact
timothy degroot
4100 hamline avenue north
saint paul, MN 55112
6515826168
MDR Report Key17033153
MDR Text Key316254393
Report Number2124215-2023-27594
Device Sequence Number1
Product Code LWS
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 06/02/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/31/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberA219
Device Catalogue NumberA219
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/01/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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