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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 (CRT-D)
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BOSTON SCIENTIFIC CORPORATION DYNAGEN X4 CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) Back to Search Results
Model Number G158
Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Unexpected Therapeutic Results (1631)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/06/2023
Event Type  malfunction  
Event Description
It was reported that the health care professional (hcp) wanted a review of reports for this cardiac resynchronization therapy defibrillator (crt-d) as there was a delay in ventricular pacing after the shock.Technical services (ts) reviewed the reports and noted that this is normal device operation.Ts also noted that there were small signals on the right ventricular (rv) channels that were sensed.Ts provided a potential cause.The device remains in use.No adverse patient effects were reported.
 
Event Description
It was reported that the health care professional (hcp) wanted a review of reports for this cardiac resynchronization therapy defibrillator (crt-d) as there was a delay in ventricular pacing after the shock.Technical services (ts) reviewed the reports and noted that this is normal device operation.Ts also noted that there were small signals on the right ventricular (rv) channels that were sensed.Ts provided a potential cause.The device remains in use.No adverse patient effects were reported.Subsequently, the device was explanted and replaced due to normal battery depletion.The device was returned for analysis.No adverse patient effects were reported.
 
Manufacturer Narrative
The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies dimensional analysis of the header was completed.Each port measured as expected.The device was then exposed to simulated heart load conditions, and the defibrillation, pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.
 
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Brand Name
DYNAGEN X4 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 55112-5798
6515826168
MDR Report Key18327661
MDR Text Key330575017
Report Number2124215-2023-71124
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 Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/12/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date12/17/2015
Device Model NumberG158
Device Catalogue NumberG158
Device Lot Number101072
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/14/2023
Supplement Dates Manufacturer Received04/11/2024
Supplement Dates FDA Received04/12/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/19/2014
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 Age72 YR
Patient SexMale
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