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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESONATE X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
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BOSTON SCIENTIFIC CORPORATION RESONATE X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D Back to Search Results
Model Number G447
Device Problems Failure to Capture (1081); Over-Sensing (1438); Pacing Problem (1439); Failure to Read Input Signal (1581)
Patient Problem Asystole (4442)
Event Date 01/17/2024
Event Type  malfunction  
Event Description
It was reported that the cardiac resynchronization therapy defibrillator (crt-d) was newly implanted and two days post-implant, an asystole was recorded on the ecg.There were several p-waves and no qrs and there were no right ventricular (rv) pacing spikes visible on the ecg strip.The patient performed a patient initiated interrogations (pii) and data was transmitted.Boston scientific technical services reviewed the available data and observed possible oversensing present for this device which may be related to the documented asystole.In the presenting egm from latitude there was a small signal compared to r-wave deflection.Troubleshooting steps were provided to exclude mechanical issues and or lead impairment.Additionally, boston scientific was notified that the patient had more asystole.New images were provided for review and technical services indicated that the right ventricular (rv) lead does appear to be possibly in septal position which was something the healthcare professional was also contemplating.The rv coil in the position reported with an integrated lead may add risk of oversensing.Also, the shock vector may be affected if the rv coil is not covering all the necessary heart mass.The physician is planning a potential invasive lead positioning revision.There were no additional adverse patient effects reported.The device and rv lead remain in-service.
 
Event Description
It was reported that the cardiac resynchronization therapy defibrillator (crt-d) was newly implanted and two days post-implant, an asystole was recorded on the ecg.There were several p-waves and no qrs and there were no right ventricular (rv) pacing spikes visible on the ecg strip.The patient performed a patient initiated interrogations (pii) and data was transmitted.Boston scientific technical services reviewed the available data and observed possible oversensing present for this device which may be related to the documented asystole.In the presenting egm from latitude there was a small signal compared to r-wave deflection.Troubleshooting steps were provided to exclude mechanical issues and or lead impairment.Additionally, boston scientific was notified that the patient had more asystole.New images were provided for review and technical services indicated that the right ventricular (rv) lead does appear to be possibly in septal position which was something the healthcare professional was also contemplating.The rv coil in the position reported with an integrated lead may add risk of oversensing.Also, the shock vector may be affected if the rv coil is not covering all the necessary heart mass.The physician is planning a potential invasive lead positioning revision.There were no additional adverse patient effects reported.The device and rv lead remain in-service.Additional information was provided, it was reported that the rv lead was repositioned in the apex.No additional adverse patient effects were reported.The device and rv lead remain in-service.
 
Manufacturer Narrative
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Please refer to b5 describe event or problem for more information regarding the specific circumstances of this event.
 
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Brand Name
RESONATE X4 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 Key18640785
MDR Text Key334553056
Report Number2124215-2024-06232
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodePO
PMA/PMN Number
P010012/S436
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/08/2024
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 Model NumberG447
Device Catalogue NumberG447
Device Lot Number322045
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/17/2024
Initial Date FDA Received02/05/2024
Supplement Dates Manufacturer Received02/06/2024
Supplement Dates FDA Received02/08/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/21/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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