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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN X4 CRT-D; IMPLANTABLE CHF GENERATOR
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BOSTON SCIENTIFIC CORPORATION DYNAGEN X4 CRT-D; IMPLANTABLE CHF GENERATOR Back to Search Results
Model Number G158
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Staphylococcus Aureus (2058)
Event Date 10/11/2018
Event Type  Injury  
Event Description
Boston scientific received information that this cardiac resynchronization therapy defibrillator (crt-d) was part of a system revision due to (b)(6) bacteremia.There were no additional adverse patient effects reported.The crt-d was explanted.
 
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Brand Name
DYNAGEN X4 CRT-D
Type of Device
IMPLANTABLE CHF GENERATOR
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 Key8250269
MDR Text Key133132854
Report Number2124215-2018-62917
Device Sequence Number1
Product Code NIK
UDI-Device Identifier00802526534904
UDI-Public00802526534904
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 01/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date01/02/2020
Device Model NumberG158
Device Catalogue NumberG158
Device Lot Number184749
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/02/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/11/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/02/2018
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 Age83 YR
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