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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBLEM S-ICD; IMPLANTABLE LEAD
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BOSTON SCIENTIFIC CORPORATION EMBLEM S-ICD; IMPLANTABLE LEAD Back to Search Results
Model Number 3501
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); No Code Available (3191)
Event Date 02/14/2020
Event Type  Injury  
Event Description
It was reported that this system was explanted due to erosion.There were no additional adverse patient effects.
 
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Brand Name
EMBLEM S-ICD
Type of Device
IMPLANTABLE LEAD
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 Key11283689
MDR Text Key230433156
Report Number2124215-2021-03000
Device Sequence Number1
Product Code LWS
UDI-Device Identifier00802526599200
UDI-Public00802526599200
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P110042/S077
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 02/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Expiration Date07/01/2021
Device Model Number3501
Device Catalogue Number3501
Device Lot Number160965
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/31/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2019
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;
Patient Age57 YR
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