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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); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Failure to Read Input Signal (1581)
Patient Problem Shock from Patient Lead(s) (3162)
Event Date 03/21/2024
Event Type  malfunction  
Event Description
It was reported that during a remote monitoring check the physician noticed this subcutaneous implantable cardioverter defibrillator (s-icd) had delivered an inappropriate shock due to a low signal and possible myopotential oversensing.The physician contacted the patient and scheduled a follow-up in office.Technical services was also contacted for further review.Besides the inappropriate shock, no other adverse patient effects were reported.This product remains in service.
 
Manufacturer Narrative
This device remains implanted; therefore, technical analysis cannot be conducted.If pertinent information is provided in the future, a supplemental report will be submitted.
 
Event Description
It was reported that during a remote monitoring check the physician noticed this subcutaneous implantable cardioverter defibrillator (s-icd) had delivered an inappropriate shock due to a low signal and possible myopotential oversensing.The physician contacted the patient and scheduled a follow-up in office.Technical services was also contacted for further review.Besides the inappropriate shock, no other adverse patient effects were reported.This product remains in service.Additional information: the patient was seen in ambulatory follow-up and troubleshooting was performed.The device was programmed to secondary vector 2x, and the patient will be monitored via latitude (twice per week) and in the scheduled follow-ups.
 
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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 Key18989348
MDR Text Key338755609
Report Number2124215-2024-18604
Device Sequence Number1
Product Code LWS
Combination Product (y/n)N
Reporter Country CodeIT
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 04/24/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2024
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
Device Lot Number177729
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/24/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/19/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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