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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Purulent Discharge (1812); Unspecified Infection (1930); Pocket Erosion (2013); Sepsis (2067)
Event Date 09/15/2021
Event Type  Injury  
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) was part of a system revision due to infection with sepsis.The patient was treated with intravenous antibiotics.There were no additional adverse patient effects reported.The crt-d was explanted.
 
Manufacturer Narrative
This supplemental report is being filed to capture the pertinent information of a new patient code added to h6.
 
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was part of a system revision due to infection with sepsis.The patient was treated with intravenous antibiotics.There were no additional adverse patient effects reported.The crt-d was explanted.Additional information received indicates that the device was protruding under the armpit, had buildup of pus and was red and inflamed.There were no additional adverse patient effects 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 Key12661891
MDR Text Key277346146
Report Number2124215-2021-30384
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 Consumer,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date04/02/2021
Device Model NumberG125
Device Catalogue NumberG125
Device Lot Number133098
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/30/2021
Initial Date FDA Received10/19/2021
Supplement Dates Manufacturer Received02/15/2022
Supplement Dates FDA Received04/26/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/12/2019
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; Required Intervention;
Patient Age73 YR
Patient SexMale
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