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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MOMENTUM X4 CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
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BOSTON SCIENTIFIC CORPORATION MOMENTUM X4 CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR Back to Search Results
Model Number G138
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Purulent Discharge (1812); Unspecified Infection (1930)
Event Date 09/01/2021
Event Type  Injury  
Event Description
It was reported that an infection was noted during an attempted lead implant.The attempted right atrial (ra) lead was removed and discarded.The existing device system, including this cardiac resynchronization therapy defibrillator (crt-d), and a left ventricular (lv) lead is expect to be scheduled for explant.The local area sales representative was contacted for additional information.At this time, no further information is available.Should additional information become available this report will be updated.No adverse patient effects were reported.
 
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Brand Name
MOMENTUM X4 CRT-D
Type of Device
CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key12755152
MDR Text Key280260053
Report Number2124215-2021-34318
Device Sequence Number1
Product Code NIK
UDI-Device Identifier00802526589188
UDI-Public00802526589188
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,foreig
Type of Report Initial
Report Date 11/04/2021
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 Date03/04/2022
Device Model NumberG138
Device Catalogue NumberG138
Device Lot Number384973
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/14/2021
Initial Date FDA Received11/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/18/2020
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) Required Intervention;
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