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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 G124
Device Problems Failure to Read Input Signal (1581); Low impedance (2285); Battery Problem (2885)
Patient Problem Sepsis (2067)
Event Date 02/16/2024
Event Type  Injury  
Event Description
It was reported that the health care professional (hcp) called technical services (ts) to review this cardiac resynchronization therapy defibrillator (crt-d) system stored data due to concerns of premature battery depletion (pbd).Data analysis was performed, and evidence showed that the device battery was depleting as expected.Ts stated that the increase in power consumption appeared to be driven by the left ventricular (lv) lead current programming and low impedance measurements on the lead.Further review of the impedance measurement trending data showed a drop of the pacing impedances on the right atrial (ra) and right ventricular (rv) leads.Ts also noted that a drop in shock impedances was observed on the rv channel as well.It was noted the drop in the shock and pacing impedances remained in the normal range the hcp noted that the patient had recently been hospitalized in intensive care unit (icu) due to sepsis.At this time, the crtd remains in service.No additional adverse patient effects were reported.
 
Event Description
It was reported that the health care professional (hcp) called technical services (ts) to review this cardiac resynchronization therapy defibrillator (crt-d) system stored data due to concerns of premature battery depletion (pbd).Data analysis was performed, and evidence showed that the device battery was depleting as expected.Ts stated that the increase in power consumption appeared to be driven by the left ventricular (lv) lead current programming and low impedance measurements on the lead.Further review of the impedance measurement trending data showed a drop of the pacing impedances on the right atrial (ra) and right ventricular (rv) leads.Ts also noted that a drop in shock impedances was observed on the rv channel as well.It was noted the drop in the shock and pacing impedances remained in the normal range the hcp noted that the patient had recently been hospitalized in intensive care unit (icu) due to sepsis.At this time, the crtd remains in service.No additional adverse patient effects were reported.Additional information was received that reported that a change in patient condition led to sepsis and the patient was given iv antibiotics which cleared the infection.The physician plans on continuing to monitor the patient at this time.No additional adverse patient effects were reported.The product remains in service.
 
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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 Key18934080
MDR Text Key338032736
Report Number2124215-2024-16580
Device Sequence Number1
Product Code NIK
UDI-Device Identifier00802526589102
UDI-Public00802526589102
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/22/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date11/20/2020
Device Model NumberG124
Device Catalogue NumberG124
Device Lot Number492747
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/21/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/12/2018
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 Outcome(s) Hospitalization;
Patient Age75 YR
Patient SexFemale
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