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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 Problems Pacing Problem (1439); Use of Device Problem (1670)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/15/2020
Event Type  malfunction  
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) patient was experiencing inappropriate pacing percentages and therapy loss, despite the device programmed to left ventricular-only mode. Boston scientific technical services was contacted and it was discussed that a right ventricular (rv) lead was not implanted in the system, which is off-label usage. Because the crt-p operation is based on right ventricular (rv) based timing, it was strongly recommended to implant a rv lead to resolve the event. It is unknown if the therapy loss resulted in asystole or a health impact. Additional information has been requested regarding the event resolution and physician name, but has not yet been received. At this time, the device remains implanted and no additional adverse patient consequences were reported.
 
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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 Key11228012
MDR Text Key228620443
Report Number2124215-2021-01902
Device Sequence Number1
Product Code NKE
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,Followup
Report Date 04/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/19/2021
Device Model NumberU228
Device Catalogue NumberU228
Device Lot Number744118
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 Received03/03/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/05/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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