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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 G151
Device Problem Difficult to Insert (1316)
Patient Problem Asystole (4442)
Event Date 01/03/2024
Event Type  malfunction  
Event Description
It was reported that, during the implant procedure of this cardiac resynchronization therapy defibrillator (crt-d), the patient went asystolic for five seconds.The physician indicated that there were miscommunications when hooking up the leads to this crt-d and where backup pacing was coming from.This crt-d was successfully implanted.No adverse patient effects were reported.
 
Manufacturer Narrative
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation noted evidence indicating difficulty may have been encountered fully inserting an df-1 lead into the header of this device resulting asystolic for five seconds.Please refer to the description for more information regarding the specific circumstances of this event.
 
Event Description
It was reported that, during the implant procedure of this cardiac resynchronization therapy defibrillator (crt-d), the patient went asystolic for five seconds.The physician indicated that there were miscommunications when hooking up the leads to this crt-d and where backup pacing was coming from.This crt-d was successfully implanted.No adverse patient 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
cashel road
clonmel
EI  
Manufacturer Contact
timothy degroot
4100 hamline avenue north
saint paul, MN 55112
6515826168
MDR Report Key18540743
MDR Text Key333217818
Report Number2124215-2024-02634
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/12/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberG151
Device Catalogue NumberG151
Device Lot Number155529
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/02/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/21/2022
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 Age65 YR
Patient SexMale
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