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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBLEM S-ICD; IMPLANTABLE ELECTRODE
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BOSTON SCIENTIFIC CORPORATION EMBLEM S-ICD; IMPLANTABLE ELECTRODE Back to Search Results
Model Number 3501
Device Problems Signal Artifact/Noise (1036); Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem Shock from Patient Lead(s) (3162)
Event Date 03/20/2024
Event Type  malfunction  
Event Description
It was reported that the night following implant, this subcutaneous implantable cardioverter defibrillator (s-icd) exhibited oversensing of noise resulting in an inappropriate shock and several stored untreated episodes.An x-ray was performed and confirmed the presence of air around the electrode.This device system remains in service and will continue to be monitored.No adverse patient effects were reported.
 
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Brand Name
EMBLEM S-ICD
Type of Device
IMPLANTABLE ELECTRODE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
road 698, lot no. 12
dorado PR 00646 -260
*   00646-2602
Manufacturer Contact
timothy degroot
4100 hamline avenue north
saint paul, MN 55112
6515826168
MDR Report Key19005916
MDR Text Key338941961
Report Number2124215-2024-19157
Device Sequence Number1
Product Code LWS
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
P110042/S077
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
Report Date 03/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number3501
Device Catalogue Number3501
Device Lot Number247528
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/20/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/18/2023
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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