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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VALITUDE CRT-P IMPLANTABLE DEVICE

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BOSTON SCIENTIFIC CORPORATION VALITUDE CRT-P IMPLANTABLE DEVICE Back to Search Results
Model Number U125
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Patient Involvement (2645)
Event Date 04/05/2019
Event Type  malfunction  
Manufacturer Narrative
No further information is available at this time. If this device is returned and analysis is completed, this report will be updated at that time.
 
Event Description
It was reported that this device recorded a code 1003 during pre-implant interrogation due to exposure to cold weather. Data analysis was not completed, therefore this device is not able to implanted. No patient involvement.
 
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Brand NameVALITUDE CRT-P
Type of DeviceIMPLANTABLE DEVICE
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 Key8765922
MDR Text Key150257219
Report Number2124215-2019-12528
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030005/S113
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/17/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date04/30/2020
Device Model NumberU125
Device Catalogue NumberU125
Device Lot Number709229
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/25/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/26/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/16/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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