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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VISIONIST X4 CRT-P IMPLANTABLE DEVICE

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BOSTON SCIENTIFIC CORPORATION VISIONIST X4 CRT-P IMPLANTABLE DEVICE Back to Search Results
Model Number U228
Device Problem High impedance (1291)
Patient Problem Insufficient Information (4580)
Event Date 03/07/2021
Event Type  malfunction  
Event Description
It was reported that there was a lead safety switch on the right atrial lead. Boston scientific technical services (ts) was contacted for a review of the data, and ts confirmed high, out-of-range pace impedance of greater than 2000 ohms. Programming options were discussed. No adverse patient effects were reported.
 
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Brand NameVISIONIST X4 CRT-P
Type of DeviceIMPLANTABLE DEVICE
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 Key12054310
MDR Text Key258088087
Report Number2124215-2021-12805
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030005/S138
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/20/2021
Device Model NumberU228
Device Catalogue NumberU228
Device Lot Number742930
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/14/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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