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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBLEM MRI S-ICD; IMPLANTABLE DEVICE
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BOSTON SCIENTIFIC CORPORATION EMBLEM MRI S-ICD; IMPLANTABLE DEVICE Back to Search Results
Model Number A219
Device Problems Failure to Sense (1559); Low impedance (2285)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/11/2024
Event Type  Injury  
Event Description
It was reported that at a recent follow-up appointment the impedance of the subcutaneous implantable cardioverter defibrillator (s-icd) system was less than 30 ohms and there was a lack of sensing in the primary vector.X-ray revealed that the electrode had pulled back, resulting in sense b being in close proximity to the pocket.The patient underwent complete system replacement.No additional adverse patient effects were reported.
 
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Brand Name
EMBLEM MRI S-ICD
Type of Device
IMPLANTABLE DEVICE
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 Key18992530
MDR Text Key338811507
Report Number2124215-2024-18859
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 Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 03/28/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2024
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 Number302414
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/22/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/15/2024
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; Hospitalization;
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