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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 Hematoma (1884); No Code Available (3191)
Event Date 11/10/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.(b)(4).
 
Event Description
It was reported that this patient with this cardiac resynchronization therapy defibrillator (crt-d) developed hematoma that requiring a pocket revision.Revision was scheduled.Additional information obtained from the field which indicated that a pocket revision was done.The device remains in service.No additional adverse patient effects were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.Patient code 3191 captures the reportable event of surgery.The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.The device was then exposed to simulated heart load conditions, and the defibrillation, pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.
 
Event Description
It was reported that this patient with this cardiac resynchronization therapy defibrillator (crt-d) developed hematoma that requiring a pocket revision.Revision was scheduled.Additional information obtained from the field which indicated that a pocket revision was done.The device remains in service.No additional adverse patient effects were 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
MDR Report Key11220862
MDR Text Key228399431
Report Number2124215-2021-01671
Device Sequence Number1
Product Code NIK
UDI-Device Identifier00802526589126
UDI-Public00802526589126
Combination Product (y/n)N
PMA/PMN Number
P010012/S436
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 07/27/2021
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 Date01/27/2022
Device Model NumberG125
Device Catalogue NumberG125
Device Lot Number138318
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/01/2021
Initial Date Manufacturer Received 11/10/2020
Initial Date FDA Received01/24/2021
Supplement Dates Manufacturer Received05/31/2021
Supplement Dates FDA Received07/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age63 YR
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