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 MOMENTUM X4 CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
  • 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 MOMENTUM X4 CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR Back to Search Results
Model Number G138
Device Problems Signal Artifact/Noise (1036); Failure to Capture (1081); Pacing Problem (1439); Under-Sensing (1661); High Capture Threshold (3266)
Patient Problems Vomiting (2144); Syncope/Fainting (4411)
Event Date 04/23/2023
Event Type  malfunction  
Event Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) system presented to the emergency department with syncope and vomit.Right ventricular (rv) lead thresholds were high and noise was noted, and left ventricular (lv) lead had exhibited loss of pacing and sensing.Technical services (ts) was consulted and it was noted that right ventricular (rv) auto threshold test had been interrupted during a telemetry session.This crt-d system remains in service.No additional adverse patient effects were reported.
 
Event Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) system presented to the emergency department with syncope and vomit.Right ventricular (rv) lead thresholds were high and noise was noted, and left ventricular (lv) lead had exhibited loss of pacing and sensing.Technical services (ts) was consulted and it was noted that right ventricular (rv) auto threshold test had been interrupted during a telemetry session.This crt-d system remains in service.No additional adverse patient effects were reported.Additional information was received and syncope was attributed to loss of capture, the system was reprogrammed.No adverse patient effects were reported.
 
Manufacturer Narrative
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 no anomalies.Dimensional analysis of the header was completed.Each port measured as expected.The device was then exposed to simulated heart load conditions, and the defibrillation, pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.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 the patient with this cardiac resynchronization therapy defibrillator (crt-d) system presented to the emergency department with syncope and vomit.Right ventricular (rv) lead thresholds were high and noise was noted, and left ventricular (lv) lead had exhibited loss of pacing and sensing.Technical services (ts) was consulted and it was noted that right ventricular (rv) auto threshold test had been interrupted during a telemetry session.This crt-d system remains in service.No additional adverse patient effects were reported.Additional information was received and syncope was attributed to loss of capture, the system was reprogrammed.No adverse patient effects were reported.Additional information was received and the right ventricular (rv) lead was explanted due to lead failure, the crt-d was explanted due to therapy upgrade.No additional adverse patient effects were reported.The product has returned to boston scientific.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MOMENTUM X4 CRT-D
Type of Device
CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
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 Key16938649
MDR Text Key315290728
Report Number2124215-2023-24238
Device Sequence Number1
Product Code NIK
UDI-Device Identifier00802526589188
UDI-Public00802526589188
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 Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 11/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/16/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date06/02/2023
Device Model NumberG138
Device Catalogue NumberG138
Device Lot Number388205
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/31/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/17/2021
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 Age67 YR
Patient SexMale
-
-