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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 Pocket Stimulation (1463); High Capture Threshold (3266)
Patient Problems Device Overstimulation of Tissue (1991); Pain (1994)
Event Date 03/06/2024
Event Type  Injury  
Event Description
It was reported that the patient was seen in clinic due to arm pain, in sling, due to stimulation issues on this recently implanted cardiac resynchronization therapy defibrillator (crt-d).Physician advised reprogramming and further follow-up if the condition persists.Technical services (ts) was consulted, and further troubleshooting was discussed for the recently implanted right ventricular (rv) lead and left ventricular (lv) lead, including x-ray.Recommendations communicated to the physician, however reprogramming and continued follow-up are expected.At this time, the device and leads remain in service.No additional adverse patient effects were reported.
 
Event Description
It was reported that the patient was seen in clinic due to arm pain, in sling, due to stimulation issues on this recently implanted cardiac resynchronization therapy defibrillator (crt-d).Physician advised reprogramming and further follow-up if the condition persists.Technical services (ts) was consulted, and further troubleshooting was discussed for the recently implanted right ventricular (rv) lead and left ventricular (lv) lead, including x-ray.Recommendations communicated to the physician, however reprogramming and continued follow-up are expected.At this time, the device and leads remain in service.No additional adverse patient effects were reported.
 
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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 Key18984185
MDR Text Key338659451
Report Number2124215-2024-18395
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010012/S436
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/26/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberG447
Device Catalogue NumberG447
Device Lot Number303892
Was Device Available for Evaluation? No
Date Manufacturer Received03/06/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/21/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age59 YR
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