Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
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
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Sense (1559); Unexpected Therapeutic Results (1631); Under-Sensing (1661)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/09/2021
Event Type  Injury  
Manufacturer Narrative
The device has been returned for analysis.This report will be updated upon completion of analysis.
 
Event Description
It was reported that this patient had underwent two ablation procedures for a ventricular tachycardia and an alert for signal artifact monitor (sam) episodes occurred on their cardiac resynchronization therapy defibrillator (crt-d) device.The patient was subsequently seen at a different healthcare facility in a different state.It was indicated that the right atrial (ra) lead was checked and found to be unable to pace or sense.The ra lead was also noted to exhibit undersensing and high thresholds.As a result, the patient was brought in for a ra lead replacement procedure.The ra lead was explanted and a new ra lead was implanted.The new ra lead exhibited appropriate function and measurements when connected to a pacing system analyzer (psa) but when the lead was connected to the existing crt-d device, the lead exhibited no functionality or measurements.The ra lead was reconnected to the psa and again exhibited appropriate function and measurements but when it was reconnected to the crt-d device, it again exhibited no functionality or measurements.In response, the crt-d device was also explanted and replaced during the procedure.The new ra lead and new crt-d device exhibited normal functionality and the procedure was successfully completed.The boston scientific representative found out after the procedure that ra sensing had been off and inquired if this could have occurred as a result of the sam episodes.Boston scientific technical services (ts) discussed that this was not part of the sam feature.It was confirmed that ra sensing was on approximately two and a half weeks before the replacement procedure.No additional adverse patient effects were reported.
 
Manufacturer Narrative
The device has been returned for analysis.This report will be updated upon completion of analysis.The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted scratches.There is a hole in the right ventricular (rv) seal plug.The other seal plugs are intact, and the set screws operate normally.The device battery is at beginning of life (bol) status.The device was exposed to simulated heart load conditions, and the pacing and sensing functions were tested on all three channels.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.
 
Event Description
It was reported that this patient had underwent two ablation procedures for a ventricular tachycardia and an alert for signal artifact monitor (sam) episodes occurred on their cardiac resynchronization therapy defibrillator (crt-d) device.The patient was subsequently seen at a different healthcare facility in a different state.It was indicated that the right atrial (ra) lead was checked and found to be unable to pace or sense.The ra lead was also noted to exhibit undersensing and high thresholds.As a result, the patient was brought in for a ra lead replacement procedure.The ra lead was explanted and a new ra lead was implanted.The new ra lead exhibited appropriate function and measurements when connected to a pacing system analyzer (psa) but when the lead was connected to the existing crt-d device, the lead exhibited no functionality or measurements.The ra lead was reconnected to the psa and again exhibited appropriate function and measurements but when it was reconnected to the crt-d device, it again exhibited no functionality or measurements.In response, the crt-d device was also explanted and replaced during the procedure.The new ra lead and new crt-d device exhibited normal functionality and the procedure was successfully completed.The boston scientific representative found out after the procedure that ra sensing had been off and inquired if this could have occurred as a result of the sam episodes.Boston scientific technical services (ts) discussed that this was not part of the sam feature.It was confirmed that ra sensing was on approximately two and a half weeks before the replacement procedure.No additional adverse patient effects were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 degroot
4100 hamline avenue north
saint paul, MN 55112
6515826168
MDR Report Key13262303
MDR Text Key284111237
Report Number2124215-2022-00593
Device Sequence Number1
Product Code NIK
UDI-Device Identifier00802526589539
UDI-Public00802526589539
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 Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date01/05/2023
Device Model NumberG447
Device Catalogue NumberG447
Device Lot Number252173
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/08/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/19/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age75 YR
Patient SexMale
-
-