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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
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BOSTON SCIENTIFIC CORPORATION DYNAGEN CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D Back to Search Results
Model Number G154
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Syncope (1610); Anemia (1706); Atrial Flutter (1730); Dehydration (1807); Vaso-Vagal Response (2661); Syncope/Fainting (4411)
Event Date 06/18/2019
Event Type  Injury  
Manufacturer Narrative
The local area sales representative was contacted for additional information.At this time, no further information is available.Should additional information become available this report will be updated.
 
Event Description
It was reported that the patient implanted with this cardiac resynchronization therapy defibrillator (crt-d) experienced a syncopal episode.Review of stored device memory noted no stored episodes that corresponded with the syncope, however, noted the patient was in an ongoing atrial tachy response (atr) mode switch due to atrial flutter.Available information indicates that this product remains implanted and in service.No additional adverse patient effects were reported.
 
Event Description
It was reported that the root cause of syncope was related to the patient's diagnosis of orthostatic hypotension with a possible vasovagal component.The patient was also diagnosed with several other medical issues unrelated to the device.
 
Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
 
Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.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.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.
 
Event Description
It was reported that the patient implanted with this cardiac resynchronization therapy defibrillator (crt-d) experienced a syncopal episode.Review of stored device memory noted no stored episodes that corresponded with the syncope, however, noted the patient was in an ongoing atrial tachy response (atr) mode switch due to atrial flutter.Available information indicates that this product remains implanted and in service.No additional adverse patient effects were reported.It was reported that the root cause of syncope was related to the patient's diagnosis of orthostatic hypotension with a possible vasovagal component.The patient was also diagnosed with several other medical issues unrelated to the device.It was reported that the device was later explanted and replaced for reported normal battery depletion.The product has been received for analysis.
 
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Brand Name
DYNAGEN CRT-D
Type of Device
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH 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 Key8847553
MDR Text Key152837606
Report Number2124215-2019-14719
Device Sequence Number1
Product Code NIK
UDI-Device Identifier00802526534652
UDI-Public00802526534652
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,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 01/17/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date01/13/2017
Device Model NumberG154
Device Catalogue NumberG154
Device Lot Number100578
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/18/2019
Initial Date FDA Received07/31/2019
Supplement Dates Manufacturer Received08/02/2019
01/16/2023
Supplement Dates FDA Received09/30/2019
01/17/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/13/2015
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) Life Threatening;
Patient Age84 YR
Patient SexMale
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