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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN X4 CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
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BOSTON SCIENTIFIC CORPORATION DYNAGEN X4 CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR Back to Search Results
Model Number G158
Device Problems Failure to Capture (1081); Pacing Problem (1439); Migration (4003)
Patient Problems Bradycardia (1751); Syncope/Fainting (4411); Twiddlers Syndrome (4563)
Event Date 06/11/2023
Event Type  Injury  
Event Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) presented to the emergency room due to bradycardia and syncopal episodes.A right ventricular (rv) lead dislodgement was confirmed.The left ventricular (lv) lead was noted to exhibit loss of capture (loc).Reprogramming was performed and capture was obtained according to the emergency room physician.The patient will be transferred to a different healthcare facility to be evaluated by the following physician.No additional adverse patient effects were reported.At this time, this device system remains in service.
 
Event Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) presented to the emergency room due to bradycardia and syncopal episodes.A right ventricular (rv) lead dislodgement was confirmed.The left ventricular (lv) lead was noted to exhibit loss of capture (loc).Reprogramming was performed and capture was obtained according to the emergency room physician.The patient will be transferred to a different healthcare facility to be evaluated by the following physician.No additional adverse patient effects were reported.At this time, this device system remains in service.
 
Event Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) presented to the emergency room due to bradycardia and syncopal episodes.A right ventricular (rv) lead dislodgement was confirmed.The left ventricular (lv) lead was noted to exhibit loss of capture (loc).Reprogramming was performed and capture was obtained according to the emergency room physician.The patient will be transferred to a different healthcare facility to be evaluated by the following physician.No additional adverse patient effects were reported.Further information was received that this device system was explanted due to twiddlers syndrome.It is expected to receive this device for analysis.
 
Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.The baseline testing completed on the device found no failing conditions.All testing that was completed on the device passed or was not applicable, therefore no problem was detected.Device migration is known for implanted devices.Analysis of the returned product is not able to provide relevant information pertinent to these types of allegations.
 
Event Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) presented to the emergency room due to bradycardia and syncopal episodes.A right ventricular (rv) lead dislodgement was confirmed.The left ventricular (lv) lead was noted to exhibit loss of capture (loc).Reprogramming was performed and capture was obtained according to the emergency room physician.The patient will be transferred to a different healthcare facility to be evaluated by the following physician.No additional adverse patient effects were reported.Further information was received that this device system was explanted due to twiddlers syndrome.This product has been received for analysis.
 
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Brand Name
DYNAGEN X4 CRT-D
Type of Device
CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
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 Key17164251
MDR Text Key317815794
Report Number2124215-2023-31798
Device Sequence Number1
Product Code NIK
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,Followup,Followup
Report Date 04/17/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date06/09/2023
Device Model NumberG158
Device Catalogue NumberG158
Device Lot Number262312
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/11/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/23/2021
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 Age83 YR
Patient SexFemale
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