Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
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
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Fall (1848); Syncope/Fainting (4411)
Event Date 09/04/2022
Event Type  Injury  
Event Description
It was reported that this patient experienced syncope then fell and hit their head during an episode of ventricular tachycardia (vt).No additional adverse patient effects were reported.No allegations against the device were reported.Currently, this cardiac resynchronization therapy defibrillator (crt-d) remains in service.
 
Event Description
It was reported that this patient experienced syncope then fell and hit their head during an episode of ventricular tachycardia (vt).No additional adverse patient effects were reported.No allegations against the device were reported.Currently, this cardiac resynchronization therapy defibrillator (crt-d) remains in service.
 
Manufacturer Narrative
Upon further review, impact code minor injury/illness/impairment was selected to be a more appropriate description of the situation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key15493987
MDR Text Key300697152
Report Number2124215-2022-38181
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 Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/07/2022
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 Date06/14/2023
Device Model NumberG125
Device Catalogue NumberG125
Device Lot Number147447
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/06/2022
Initial Date FDA Received09/27/2022
Supplement Dates Manufacturer Received10/06/2022
Supplement Dates FDA Received10/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/29/2021
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 Age71 YR
Patient SexMale
-
-