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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 Premature Discharge of Battery (1057); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/30/2019
Event Type  malfunction  
Event Description
It was reported that a low voltage alert, code 1003, was recorded on this device pre-implant. If this model device is stored in environments where temperatures can drop below the recommended storage temperature, battery voltage readings that are low enough to set a low voltage alert may result. This appears to be the case with this device. At this time, the product has not been returned. If the product is returned, analysis will be performed and this report would be updated.
 
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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 Key9211120
MDR Text Key163008707
Report Number2124215-2019-21605
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 02/02/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/02/2020
Device Model NumberU228
Device Catalogue NumberU228
Device Lot Number734329
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/30/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/21/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/14/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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