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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)
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BOSTON SCIENTIFIC CORPORATION DYNAGEN CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) Back to Search Results
Model Number G150
Device Problem Defective Device (2588)
Patient Problems Hemorrhage/Bleeding (1888); Valvular Insufficiency/ Regurgitation (4449)
Event Date 12/06/2023
Event Type  Injury  
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) system was explanted.The physician opted to place the rv lead on the outside of the heart.The other right ventricular (rv) lead was explanted due to severe tricuspid regurgitation.The patient experienced severe blood loss at the beginning of the procedure after sternotomy was performed that required lifesaving intervention.Patient was then stable, and the physician proceeded with the implant of new device and lead.No additional patient adverse effects were reported.
 
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) system was explanted.The physician opted to place the rv lead on the outside of the heart.The other right ventricular (rv) lead was explanted due to severe tricuspid regurgitation.The patient experienced severe blood loss at the beginning of the procedure after sternotomy was performed that required lifesaving intervention.Patient was then stable, and the physician proceeded with the implant of new device and lead.No additional patient adverse effects were reported.
 
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Brand Name
DYNAGEN CRT-D
Type of Device
CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112 5798
Manufacturer Contact
timothy degroot
4100 hamline avenue north
saint paul, MN 55112
6515826168
MDR Report Key18314317
MDR Text Key330309413
Report Number2124215-2023-70536
Device Sequence Number1
Product Code NIK
UDI-Device Identifier00802526534614
UDI-Public00802526534614
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
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/08/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date04/06/2019
Device Model NumberG150
Device Catalogue NumberG150
Device Lot Number486206
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/03/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/24/2017
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; Required Intervention;
Patient Age69 YR
Patient SexFemale
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