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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 Unspecified Infection (1930); No Code Available (3191)
Event Date 11/23/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.(b)(4).
 
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was part of a system revision due to infection that stemmed from osteomyelitis.The leg was removed prior to the system explant.The device was not the cause of the infection.There were no additional adverse patient effects reported.The 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 the device was not confirmed.The device was analyzed, passed all the baseline tests and exhibited normal device functions.No problem was detected.This supplemental is being filed to capture the return date and the product investigation results.
 
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was part of a system revision due to infection that stemmed from osteomyelitis.The leg was removed prior to the system explant.The device was not the cause of the infection.There were no additional adverse patient effects reported.The 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
MDR Report Key11201054
MDR Text Key227742819
Report Number2124215-2021-00933
Device Sequence Number1
Product Code NIK
UDI-Device Identifier00802526534591
UDI-Public00802526534591
Combination Product (y/n)N
PMA/PMN Number
P010012/S341
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 04/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date03/12/2017
Device Model NumberG148
Device Catalogue NumberG148
Device Lot Number131607
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/21/2021
Date Manufacturer Received02/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age68 YR
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