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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VALITUDE X4 CRT-P; IMPLANTABLE DEVICE

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BOSTON SCIENTIFIC CORPORATION VALITUDE X4 CRT-P; IMPLANTABLE DEVICE Back to Search Results
Model Number U128
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Patient Involvement (2645)
Event Date 06/24/2019
Event Type  malfunction  
Manufacturer Narrative
No further information concerning this report is available at this time.This investigation will be updated should further information be provided.
 
Event Description
It was reported that this device recorded a code 1003 during pre-implant interrogation due to an unknown reason.This device was never in service.No patient involvement.
 
Manufacturer Narrative
Review of the device memory confirmed that a low voltage alert, code 1003, was recorded and that the device recorded low temperature readings prior to setting the low voltage alert.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.The battery did recover after the device was removed from the cold.
 
Event Description
This supplemental report is being filed to include product investigation results.
 
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Brand Name
VALITUDE X4 CRT-P
Type of Device
IMPLANTABLE DEVICE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key8852662
MDR Text Key153113626
Report Number2124215-2019-15069
Device Sequence Number1
Product Code NKE
UDI-Device Identifier00802526559402
UDI-Public00802526559402
Combination Product (y/n)N
PMA/PMN Number
P030005/S113
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 09/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date05/11/2020
Device Model NumberU128
Device Catalogue NumberU128
Device Lot Number732098
Was Device Available for Evaluation? No
Date Manufacturer Received08/15/2019
Patient Sequence Number1
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