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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 High impedance (1291); Noise, Audible (3273)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/19/2021
Event Type  malfunction  
Event Description
It was reported that this patient's cardiac resynchronization therapy defibrillator (crt-d) was emitting beeping tones and the health care professional (hcp) could not see any reason for it when the latitude system was checked.Technical services (ts) reviewed the case and noticed that the beeping tones alert was turned on for high right atrial out-of-range (oor) pacing impedance measurements.Further review of the patient's data revealed that 2 jumps in the impedance of over 300 ohms occurred.Ts explained the spring contact issue to the hcp and suggested bringing the patient to the clinic to turn off the oor impedance alert and further evaluations of the ra lead.The atrial impedance alert was programmed off.No further changes were performed.This crt-d remains in service and no adverse patient effects were reported.
 
Manufacturer Narrative
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited intermittent impedance measurements with no conclusive evidence of a malfunction or inadequate lead-to-device connection; please refer to the description for more information regarding the specific circumstances of this event.Investigation has determined that this type of event is likely the result of an intermittent high impedance condition associated with the device spring contact and lead terminal ring.A design enhancement was implemented in 2020 to stabilize the electrical connection between the spring contact and the lead terminal.
 
Event Description
It was reported that this patient's cardiac resynchronization therapy defibrillator (crt-d) was emitting beeping tones and the health care professional (hcp) could not see any reason for it when the latitude system was checked.Technical services (ts) reviewed the case and noticed that the beeping tones alert was turned on for high right atrial out-of-range (oor) pacing impedance measurements.Further review of the patient's data revealed that 2 jumps in the impedance of over 300 ohms occurred.Ts explained the spring contact issue to the hcp and suggested bringing the patient to the clinic to turn off the oor impedance alert and further evaluations of the ra lead.The atrial impedance alert was programmed off.No further changes were performed.This crt-d remains in service and no adverse patient effects were reported.
 
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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
6515826168
MDR Report Key13049323
MDR Text Key282559607
Report Number2124215-2021-36771
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 12/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date04/01/2016
Device Model NumberG158
Device Catalogue NumberG158
Device Lot Number103260
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/03/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/10/2014
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Age82 YR
Patient SexFemale
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