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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 G125
Device Problems Failure to Capture (1081); High impedance (1291); Connection Problem (2900)
Patient Problem Device Overstimulation of Tissue (1991)
Event Date 01/26/2021
Event Type  malfunction  
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) and left ventricular (lv) lead showed loss of capture (loc) on the presenting electrogram (egm).In addition, there were multiple high out-of-range pace impedance spikes greater than 3,000 ohms, and it was suspected that the lead-to-head connection was the cause.Technical services (ts) recommended evaluating pace vectors that did not use the ring.Additional information received reported that the patient experienced phrenic nerve stimulation in every other configuration, which is why this vector had been chosen.Thresholds taken that day were 1.5v and output was set to 2v; the safety margin was later increased and trend was programmed on.A twelve lead echocardiogram (ecg) was taken, and capture was confirmed.This crt-d system remains in service and will continue to be monitored.No additional adverse patient effects were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) and left ventricular (lv) lead showed loss of capture (loc) on the presenting electrogram (egm).In addition, there were multiple high out-of-range pace impedance spikes greater than 3,000 ohms, and it was suspected that the lead-to-head connection was the cause.Technical services (ts) recommended evaluating pace vectors that did not use the ring.Additional information received reported that the patient experienced phrenic nerve stimulation in every other configuration, which is why this vector had been chosen.Thresholds taken that day were 1.5v and output was set to 2v; the safety margin was later increased and trend was programmed on.A twelve lead echocardiogram (ecg) was taken, and capture was confirmed.This crt-d system remains in service and will continue to be monitored.No additional adverse patient effects were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.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 malfunction or inadequate lead-to-device connection; please refer to the description for more information regarding the specific circumstances of this event.Investigation has determined that this type of event is likely the result of an intermittent high impedance condition associated with the device spring contact and lead terminal ring.A design enhancement was implemented in 2020 to stabilize the electrical connection between the spring contact and the lead terminal.
 
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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 Key15739785
MDR Text Key307022152
Report Number2124215-2022-45485
Device Sequence Number1
Product Code NIK
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
Report Date 12/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date01/16/2021
Device Model NumberG125
Device Catalogue NumberG125
Device Lot Number131476
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/23/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/24/2019
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Age90 YR
Patient SexFemale
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