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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 G150
Device Problem Pocket Stimulation (1463)
Patient Problem Device Overstimulation of Tissue (1991)
Event Date 06/21/2022
Event Type  Injury  
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) device caused the patient to experience pocket stimulation.This device was programmed during outpatient to right ventricular (rv) only pacing.Subsequently, this device was explanted and replaced.No additional adverse patient effects were reported.
 
Manufacturer Narrative
The product has been received for analysis.Upon completion of the failure analysis of the complaint product, if there is any further relevant information from that review, a supplemental report will be filed.
 
Manufacturer Narrative
The product has been received for analysis.Upon completion of the failure analysis of the complaint product, if there is any further relevant information from that review, a supplemental report will be filed.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 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 this cardiac resynchronization therapy defibrillator (crt-d) device caused the patient to experience pocket stimulation.This device was programmed during outpatient to right ventricular (rv) only pacing.Subsequently, this device was explanted and replaced.No additional adverse patient effects were reported.
 
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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 Key14991781
MDR Text Key295766693
Report Number2124215-2022-25292
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,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/30/2023
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 Date07/03/2020
Device Model NumberG150
Device Catalogue NumberG150
Device Lot Number491134
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/05/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/21/2022
Initial Date FDA Received07/12/2022
Supplement Dates Manufacturer Received03/27/2023
Supplement Dates FDA Received03/30/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/23/2018
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 Age71 YR
Patient SexMale
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