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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VISIONIST CRT-P CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER

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BOSTON SCIENTIFIC CORPORATION VISIONIST CRT-P CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER Back to Search Results
Model Number U225
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Patient Involvement (2645)
Event Date 01/14/2019
Event Type  malfunction  
Event Description
It was reported that a low voltage alert, code 1003, was recorded on this cardiac resynchronization therapy pacemaker (crt-p) 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. This device was not implanted and will be returned for analysis. No adverse patient effects were reported. The product has been received for analysis. This report will be updated upon completion of analysis.
 
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Brand NameVISIONIST 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 Key8509301
MDR Text Key141767868
Report Number2124215-2019-03369
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,Followup
Report Date 06/04/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date08/21/2020
Device Model NumberU225
Device Catalogue NumberU225
Device Lot Number710329
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/05/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/04/2019
Was Device Evaluated by Manufacturer? Yes
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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