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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 Problems Premature Discharge of Battery (1057); Device Displays Incorrect Message (2591)
Patient Problem No Patient Involvement (2645)
Event Date 01/04/2019
Event Type  malfunction  
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) recorded a code 1003 pre-implant indicative of battery voltage too low for the projected remaining capacity. Data analysis confirmed code 1003 was due to cold temperature. Device voltage recovered when device was warmed. Device status remains pre-implant. No patient involvement. As no further information concerning this report is expected, our investigation is complete. This investigation will be updated should further information be provided.
 
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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 CLONMEL LIMITED
cashel road
clonmel
EI
Manufacturer Contact
timothy degroot
4100 hamline avenue north
saint paul, MN 55112
6515826168
MDR Report Key8546601
MDR Text Key142969583
Report Number2124215-2019-07313
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeIT
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
Report Date 04/24/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/25/2020
Device Model NumberU228
Device Catalogue NumberU228
Device Lot Number734866
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/14/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/06/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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