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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN X4 CRT-D; DEFIBRILLATOR
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BOSTON SCIENTIFIC CORPORATION INOGEN X4 CRT-D; DEFIBRILLATOR Back to Search Results
Model Number G148
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Endocarditis (1834); Staphylococcus Aureus (2058)
Event Date 07/18/2018
Event Type  Injury  
Event Description
Boston scientific received information that this product was part of a system revision due to infection.There were no additional adverse patient effects reported.The product was explanted.
 
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Brand Name
INOGEN X4 CRT-D
Type of Device
DEFIBRILLATOR
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
Manufacturer (Section G)
BOSTON SCIENTIFIC CLONMEL LIMITED
cashel road
,
clonmel
EI  
Manufacturer Contact
timothy degroot
4100 hamline avenue north
,
saint paul, MN 55112
6515826168
MDR Report Key8319656
MDR Text Key135495790
Report Number2124215-2019-03000
Device Sequence Number1
Product Code NIK
UDI-Device Identifier00802526534591
UDI-Public00802526534591
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010012/S341
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 02/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date07/28/2017
Device Model NumberG148
Device Catalogue NumberG148
Device Lot Number137512
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/29/2018
Initial Date FDA Received02/08/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/28/2015
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; Life Threatening; Required Intervention;
Patient Age71 YR
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