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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 Failure to Capture (1081)
Patient Problem Insufficient Information (4580)
Event Date 04/27/2021
Event Type  malfunction  
Manufacturer Narrative
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.
 
Event Description
It was reported that this cardiac resynchronization therapy pacemaker was exhibiting loss of capture on an external monitor. The available holter strips were reviewed by boston scientific technical services and confirmed there was loss of capture but there was no evidence of loss of capture from the device available information. Additionally, the patient was seen in-clinic for a follow up. The lead testing met specification and there was no evidence of any anomaly. The cardiologist will make device reprogramming changes if needed. No adverse patient effects were reported. This device 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 Key12113245
MDR Text Key260427389
Report Number2124215-2021-17136
Device Sequence Number1
Product Code NKE
UDI-Device Identifier00802526559471
UDI-Public00802526559471
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
P030005/S138
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Non-Healthcare Professional
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 Date06/28/2019
Device Model NumberU228
Device Catalogue NumberU228
Device Lot Number722706
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/03/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/12/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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