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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 Problem High impedance (1291)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/01/2023
Event Type  malfunction  
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) detected out of range and wide-ranging jumps in right atrial (ra) impedance measurements.Ra intrinsic amplitude and threshold measurements were in-range over the same time period.Of note, the ra lead is a non-boston scientific product.Technical services was consulted and confirmed this behavior is suggestive of lead fretting, which predominantly occurs when 'hybrid' systems are implanted (i.E., a boston scientific device paired with a competitor lead).However, technical services noted that since fretting is a diagnosis of exclusion, further testing to rule out mechanical lead failure should also be performed.No adverse patient effects were reported.This crt-d remains in service.
 
Manufacturer Narrative
This product has not been returned to boston scientific.As a result, laboratory analysis could not be conducted.The associated investigation determined this device exhibited intermittent impedance measurements with no conclusive evidence of a product performance issue or inadequate lead-to-device connection; please refer to the event description for more information regarding the specific circumstances of this event.Investigation has determined 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 cardiac resynchronization therapy defibrillator (crt-d) detected out of range and wide-ranging jumps in right atrial (ra) impedance measurements.Ra intrinsic amplitude and threshold measurements were in-range over the same time period.Of note, the ra lead is a non-boston scientific product.Technical services was consulted and confirmed this behavior is suggestive of lead fretting, which predominantly occurs when 'hybrid' systems are implanted (i.E., a boston scientific device paired with a competitor lead).However, technical services noted that since fretting is a diagnosis of exclusion, further testing to rule out mechanical lead failure should also be performed.No adverse patient effects were reported.This crt-d remains in service.
 
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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 Key19043340
MDR Text Key339878333
Report Number2124215-2024-20606
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeUK
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/24/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date04/25/2021
Device Model NumberG447
Device Catalogue NumberG447
Device Lot Number214957
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/23/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/07/2019
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 Age83 YR
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