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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VISIONIST CRT-P PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

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BOSTON SCIENTIFIC CORPORATION VISIONIST CRT-P PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) Back to Search Results
Model Number U225
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/01/2021
Event Type  Injury  
Event Description
It was reported that this device was explanted and replaced prophylactically, despite not being included in the advisory population. There were no further allegations against the device and it expected to be returned for analysis, but has not yet been received. No additional adverse patient effects were reported.
 
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Brand NameVISIONIST CRT-P
Type of DevicePULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
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 Key12749949
MDR Text Key280060613
Report Number2124215-2021-31315
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeNZ
PMA/PMN Number
P030005/S138
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberU225
Device Catalogue NumberU225
Device Lot Number717674
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/22/2020
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/03/2021 Patient Sequence Number: 1
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