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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 DEFIBRILLATORS (CRT-D)
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BOSTON SCIENTIFIC CORPORATION DYNAGEN X4 CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-D) Back to Search Results
Model Number G158
Device Problems High impedance (1291); Incorrect, Inadequate or Imprecise Result or Readings (1535); Unexpected Therapeutic Results (1631); Device Displays Incorrect Message (2591)
Patient Problems Arrhythmia (1721); Atrial Fibrillation (1729); Ventricular Tachycardia (2132); Electric Shock (2554)
Event Date 04/13/2019
Event Type  Injury  
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.
 
Event Description
It was reported that this patient was transported by ambulance to the emergency room after receiving multiple shocks.An external shock was required as the patient's rhythm would return shortly after being converted and therapy had been exhausted.Device interrogation revealed a code 1005.A review of the data confirmed the shocks were appropriate.There was one shocking impedance measurement greater than 125 ohms; however, shock impedance was normal during manual testing.There was also an increase in pacing impedance measurements on the left ventricular (lv) channel.A fracture of the competitive rv lead was suspected; however, x-ray did not confirm any lead damage.Defibrillation threshold (dft) testing was performed with normal test results.It was suspected that the higher lv pacing impedance measurements resulted from a vector change and testing following the change was not performed.No system changes were made, and the patient will continue to be followed.No additional adverse patient effects were reported.
 
Manufacturer Narrative
This report contains correction in section h6 patient codes and h6 impact codes.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
 
Event Description
It was reported that this patient was transported by ambulance to the emergency room after receiving multiple shocks.An external shock was required as the patient's rhythm would return shortly after being converted and therapy had been exhausted.Device interrogation revealed a code 1005.A review of the data confirmed the shocks were appropriate.There was one shocking impedance measurement greater than 125 ohms; however, shock impedance was normal during manual testing.There was also an increase in pacing impedance measurements on the left ventricular (lv) channel.A fracture of the competitive rv lead was suspected; however, x-ray did not confirm any lead damage.Defibrillation threshold (dft) testing was performed with normal test results.It was suspected that the higher lv pacing impedance measurements resulted from a vector change and testing following the change was not performed.No system changes were made, and the patient will continue to be followed.No additional adverse patient effects were reported.Additional information received indicated that this device was explanted due to normal battery depletion.No additional patient effects were reported.
 
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Brand Name
DYNAGEN X4 CRT-D
Type of Device
CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (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 Key8759079
MDR Text Key149976610
Report Number2124215-2019-12669
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 Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/29/2023
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 Date04/20/2017
Device Model NumberG158
Device Catalogue NumberG158
Device Lot Number133133
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/13/2019
Initial Date FDA Received07/03/2019
Supplement Dates Manufacturer Received11/21/2023
Supplement Dates FDA Received11/29/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/20/2015
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; Hospitalization; Required Intervention;
Patient Age65 YR
Patient SexMale
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