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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBLEM S-ICD; IMPLANTABLE DEVICE
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BOSTON SCIENTIFIC CORPORATION EMBLEM S-ICD; IMPLANTABLE DEVICE Back to Search Results
Model Number 3501
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pneumothorax (2012)
Event Date 10/31/2022
Event Type  Injury  
Event Description
It was reported that during implant of this subcutaneous implantable cardioverter defibrillator (s-icd) electrode the pulmonary pleurae was punctured resulting in a pneumothorax.The patient was noted to have experienced a low oximetry level which was addressed via medication.Approximately a week later, the electrode was successfully repositioned and remains in service.No additional adverse patient effects were reported.
 
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Brand Name
EMBLEM 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
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 Key15763302
MDR Text Key303355290
Report Number2124215-2022-46365
Device Sequence Number1
Product Code LWS
Combination Product (y/n)N
Reporter Country CodeIT
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 11/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number3501
Device Catalogue Number3501
Device Lot Number227439
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/31/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/17/2022
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; Life Threatening;
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