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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 (CRT-D)
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BOSTON SCIENTIFIC CORPORATION MOMENTUM CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) Back to Search Results
Model Number G125
Device Problems Failure to Capture (1081); High impedance (1291); High Capture Threshold (3266)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/20/2023
Event Type  malfunction  
Event Description
It was reported that the health care professional (hcp) called to report that this cardiac resynchronization therapy defibrillator (crt-d) recorded a high out of range impendence on the left ventricular (lv) lead.The patient was brought into the clinic for an in person visit and lead measurements were taken came back normal and within range.However, another high out of range impendence alert was recorded after the visit.The hcp called technical services (ts) to review the stored data.Ts reviewed the presented electrogram (egm) and lv loss of capture (loc) was noted.Ts recommended for further lead testing be performed.The device remains in service.No adverse patient effects were reported.
 
Event Description
It was reported that the health care professional (hcp) called to report that this cardiac resynchronization therapy defibrillator (crt-d) recorded a high out of range impendence on the left ventricular (lv) lead.The patient was brought into the clinic for an in person visit and lead measurements were taken came back normal and within range.However, another high out of range impendence alert was recorded after the visit.The hcp called technical services (ts) to review the stored data.Ts reviewed the presented electrogram (egm) and lv loss of capture (loc) was noted.Ts recommended for further lead testing be performed.The device remains in service.No adverse patient effects were reported.This device was not returned for analysis.The allegation(s) in this complaint have not been confirmed as there was not enough information provided in the complaint and the product has not been returned for analysis.Subsequent additional information was received reported that chest xray was performed and had indicated a possible lead fracture which may have caused the lv lead observations of high pacing threshold, high out of range impedance measurements and loss of capture (loc).The physician performed a lead revision procedure, where the lv lead was surgically abandoned and the crtd device was electively explanted due to therapy upgrade.The crtd and lv lead were successfully replaced with a new device and lead.No additional adverse patient effects were reported.
 
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Brand Name
MOMENTUM CRT-D
Type of Device
CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (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 Key18176783
MDR Text Key328626003
Report Number2124215-2023-65514
Device Sequence Number1
Product Code NIK
UDI-Device Identifier00802526589126
UDI-Public00802526589126
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,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/22/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date02/02/2024
Device Model NumberG125
Device Catalogue NumberG125
Device Lot Number151696
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/09/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/08/2022
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 Age77 YR
Patient SexMale
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