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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VISIONIST X4 CRT-P PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

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BOSTON SCIENTIFIC CORPORATION VISIONIST X4 CRT-P PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) Back to Search Results
Model Number U228
Device Problem Premature Discharge of Battery (1057)
Patient Problem Insufficient Information (4580)
Event Date 05/11/2021
Event Type  malfunction  
Event Description
It was reported that there were concerns regarding alleged premature battery depletion of this cardiac resynchronization therapy pacemaker. Furthermore, there were differing longevity estimates given over the last six months. Data analysis was performed, and it was found that this patient was in atrial fibrillation (af) and the increase in power consumption was due to high rate atrial sensing. No adverse patient effects were reported. This product remains in-service.
 
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Brand NameVISIONIST X4 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 Key12114161
MDR Text Key260565440
Report Number2124215-2021-15884
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 company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 07/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/03/2018
Device Model NumberU228
Device Catalogue NumberU228
Device Lot Number713860
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/17/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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