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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 Signal Artifact/Noise (1036); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Interrogation Problem (4017)
Patient Problem Electric Shock (2554)
Event Date 04/11/2023
Event Type  malfunction  
Event Description
It was reported that the subcutaneous implantable cardioverter defibrillator (s-icd) delivered an inappropriate shock due to myopotential oversensing.The patient went into the clinic to have the s-icd interrogated, and the field representative reported interrogation difficulties.Technical services (ts) was contacted, and ts discussed the reasons for the interrogation difficulties and helped with troubleshooting.The s-icd system remains in service.No 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 Key16758703
MDR Text Key313494630
Report Number2124215-2023-18175
Device Sequence Number1
Product Code LWS
UDI-Device Identifier00802526584404
UDI-Public00802526584404
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P110042/S058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/17/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date08/27/2022
Device Model NumberA219
Device Catalogue NumberA219
Device Lot Number129432
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/12/2023
Initial Date FDA Received04/17/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/07/2020
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 Age71 YR
Patient SexMale
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