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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
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BOSTON SCIENTIFIC CORPORATION INOGEN X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D Back to Search Results
Model Number G148
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Sepsis (2067)
Event Date 08/16/2023
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was part of a system revision due to systemic infection caused by meticillin-sensitive staphylococcus aureus.There were no additional adverse patient effects reported.This crt-d was explanted.
 
Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, additional information from product investigation indicates that the allegation against this device was not confirmed.This device was analyzed, passed all the baseline tests and exhibited normal device functions.This supplemental is being filed to capture d9: returned to manufacturer date and investigation results.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was part of a system revision due to systemic infection caused by meticillin-sensitive staphylococcus aureus.There were no additional adverse patient effects reported.This crt-d was explanted.
 
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Brand Name
INOGEN X4 CRT-D
Type of Device
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
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 Key17620852
MDR Text Key321919305
Report Number2124215-2023-45870
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 Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/02/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date06/20/2018
Device Model NumberG148
Device Catalogue NumberG148
Device Lot Number152226
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/14/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/29/2016
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) Required Intervention; Hospitalization;
Patient Age57 YR
Patient SexFemale
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