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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 Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439)
Patient Problems Presyncope (4410); Asystole (4442)
Event Date 02/08/2022
Event Type  Injury  
Event Description
It was reported that boston scientific technical services (ts) was contacted to retrieve a full record of stored events from this device. It was communicated that the physician had observed stored episodes of noisy signals from the right ventricular (rv) lead resulting in the patient feeling faint. Device data review confirmed the patient had experienced over-sensed rv noise that caused pacing inhibition and asystole. The duration of the asystole is unknown. It was hypothesized the rv lead had fractured. It was stated that the physician is planning to explant and replace the device to resolve the event, but this has not yet occurred. The rv lead is not a boston scientific product.
 
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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 Key14067592
MDR Text Key289080302
Report Number2124215-2022-05180
Device Sequence Number1
Product Code NKE
UDI-Device Identifier00802526559471
UDI-Public00802526559471
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P030005/S138
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/29/2020
Device Model NumberU228
Device Catalogue NumberU228
Device Lot Number735041
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/25/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/12/2018
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/09/2022 Patient Sequence Number: 1
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