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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VISIONIST CRT-P PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

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BOSTON SCIENTIFIC CORPORATION VISIONIST CRT-P PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) Back to Search Results
Model Number U225
Device Problem Premature Discharge of Battery (1057)
Patient Problem No Patient Involvement (2645)
Event Date 01/01/2020
Event Type  malfunction  
Manufacturer Narrative
At this time, the product has not been returned. If the product is returned, analysis will be performed and this report would be updated at that time.
 
Event Description
It was reported that this device declared a code 1003 prior to implant. Subsequently, the physician chose to use a different device. There was no patient involvement.
 
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Brand NameVISIONIST 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 Key9964749
MDR Text Key187871627
Report Number2124215-2020-05943
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 foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/25/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/28/2021
Device Model NumberU225
Device Catalogue NumberU225
Device Lot Number712039
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/31/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/30/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/14/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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