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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MOMENTUM CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
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BOSTON SCIENTIFIC CORPORATION MOMENTUM CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR Back to Search Results
Model Number G125
Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Off-Label Use (1494); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/17/2023
Event Type  malfunction  
Event Description
It was reported that during a cardiac resynchronization therapy defibrillator (crt-d) upgrade, this new crt-d showed noise over sensing on the left ventricular (lv) electrogram (egm) when the lv lead was inserted in the header.The lv lead was tested with the right ventricular (rv) lead port and the egm appeared to show normal function.A crt-d header issue was suspected.A new crt-d was used and the procedure was completed without additional adverse patient effects reported.The initially attempted crtd was retained by the field representative and will be sent back to st paul for analysis.No additional adverse patient effects were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during a cardiac resynchronization therapy defibrillator (crt-d) upgrade, this new crt-d showed noise over sensing on the left ventricular (lv) electrogram (egm) when the lv lead was inserted in the header.The lv lead was tested with the right ventricular (rv) lead port and the egm appeared to show normal function.A crt-d header issue was suspected.A new crt-d was used and the procedure was completed without additional adverse patient effects reported.The initially attempted crtd was retained by the field representative and will be sent back to st paul for analysis.No additional 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.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during a cardiac resynchronization therapy defibrillator (crt-d) upgrade, this new crt-d showed noise over sensing on the left ventricular (lv) electrogram (egm) when the lv lead was inserted in the header.The lv lead was tested with the right ventricular (rv) lead port and the egm appeared to show normal function.A crt-d header issue was suspected.A new crt-d was used and the procedure was completed without additional adverse patient effects reported.The initially attempted crtd was retained by the field representative but has been sent back to st paul for analysis.No additional adverse patient effects were reported.
 
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Brand Name
MOMENTUM 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 Key16900176
MDR Text Key314890073
Report Number2124215-2023-22858
Device Sequence Number1
Product Code NIK
UDI-Device Identifier00802526589126
UDI-Public00802526589126
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 10/04/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberG125
Device Catalogue NumberG125
Device Lot Number156971
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/24/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/13/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/24/2023
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
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