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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION VISIONIST X4 CRT-P IMPLANTABLE PACEMANKER Back to Search Results
Model Number U228
Device Problem Failure to Capture (1081)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/10/2021
Event Type  malfunction  
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) system exhibited loss of capture (loc) in the left ventricular (lv) lead. The patient was scheduled for an in-clinic check and potential reprogramming. No adverse patient effects were reported.
 
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Brand NameVISIONIST X4 CRT-P
Type of DeviceIMPLANTABLE PACEMANKER
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 Key12113499
MDR Text Key260449029
Report Number2124215-2021-14599
Device Sequence Number1
Product Code NKE
UDI-Device Identifier00802526559471
UDI-Public00802526559471
Combination Product (y/n)N
Reporter Country CodeUK
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 Date05/02/2021
Device Model NumberU228
Device Catalogue NumberU228
Device Lot Number742333
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 Received05/10/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/16/2019
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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