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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VISIONIST X4 CRT-P CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER

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BOSTON SCIENTIFIC CORPORATION VISIONIST X4 CRT-P CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER Back to Search Results
Model Number U228
Device Problem High impedance (1291)
Patient Problem Device Overstimulation of Tissue (1991)
Event Date 03/08/2022
Event Type  malfunction  
Event Description
It was reported that the left ventricular (lv) lead exhibited high out-of-range pacing impedance measurements and the pacemaker triggered a lead safety switch to unipolar mode. The patient with this lv lead also experienced diaphragmatic stimulation. The decision was made to adjust this lv lead. Approximately a few days after the adjustment, the patient presented to the emergency room with diaphragmatic stimulation again. Further evaluation was recommended. Currently, the product remains in service and no adverse patient effects were reported.
 
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Brand NameVISIONIST X4 CRT-P
Type of DeviceCARDIAC RESYNCHRONIZATION THERAPY PACEMAKER
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 Key14164807
MDR Text Key289735310
Report Number2124215-2022-12340
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 Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/05/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/20/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberU228
Device Catalogue NumberU228
Device Lot Number766809
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/11/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/29/2021
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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