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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MOMENTUM CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
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BOSTON SCIENTIFIC CORPORATION MOMENTUM CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D Back to Search Results
Model Number G124
Device Problems High impedance (1291); Noise, Audible (3273)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/25/2023
Event Type  malfunction  
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was emitting tones due to the presence of high out of range pacing impedance measurements of greater than 2000 ohms on the right atrial channel.The crt-d remains in service and no adverse patient effects were reported.
 
Manufacturer Narrative
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited intermittent impedance measurements with no conclusive evidence of a product performance issue or inadequate lead-to-device connection.Engineering analysis and testing of returned products identified that any repeated, small movements of the lead terminal ring can create wearing of the lead terminal ring and generate microscopic particles, which may accumulate and oxidize over time.This can impact the connection between the spring contact and the lead ring, resulting in intermittent changes in impedance measurements.
 
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was emitting tones due to the presence of high out of range pacing impedance measurements of greater than 2000 ohms on the right atrial channel.The crt-d remains in service and no adverse patient effects were reported.
 
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Brand Name
MOMENTUM 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 Key17548784
MDR Text Key321153947
Report Number2124215-2023-43546
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeNL
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 Physician
Remedial Action Notification
Type of Report Initial,Followup
Report Date 09/05/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date04/17/2021
Device Model NumberG124
Device Catalogue NumberG124
Device Lot Number494517
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/03/2023
Initial Date FDA Received08/15/2023
Supplement Dates Manufacturer Received09/01/2023
Supplement Dates FDA Received09/05/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2019
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Age78 YR
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