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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 Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem Shock from Patient Lead(s) (3162)
Event Date 03/14/2024
Event Type  Injury  
Event Description
It was reported that, one day after the implant procedure, the subcutaneous implantable cardioverter defibrillator (s-icd) system delivered an inappropriate shock due to oversensing.Air intake was found on the primary ring.The system was successfully revised with a good outcome, due to the s-icd and this electrode were too high.No additional 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 Key18987289
MDR Text Key338720242
Report Number2124215-2024-18530
Device Sequence Number1
Product Code LWS
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P110042/S077
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 03/27/2024
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? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number3501
Device Catalogue Number3501
Device Lot Number251512
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/14/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2023
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) Hospitalization; Required Intervention;
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