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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 Problems Signal Artifact/Noise (1036); Failure to Capture (1081)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/24/2021
Event Type  Injury  
Manufacturer Narrative
The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory. The device was then exposed to simulated heart load conditions, and the pacing, and sensing functions were tested. The device operated appropriately with no interruptions in therapy output at the returned programmed settings. A series of electrical tests was also performed, and again, normal device function was observed. Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.
 
Event Description
It was reported that this device exhibited noise and loss of capture. As such, the patient underwent additional surgical intervention and the device and the associated rv lead were explanted, replaced, and returned for analysis. No additional adverse patient effects were reported.
 
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Brand NameVALITUDE X4 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 Key11662149
MDR Text Key245325597
Report Number2124215-2021-06595
Device Sequence Number1
Product Code NKE
UDI-Device Identifier00802526559402
UDI-Public00802526559402
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,health
Reporter Occupation
Type of Report Initial
Report Date 04/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/08/2018
Device Model NumberU128
Device Catalogue NumberU128
Device Lot Number715989
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/02/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/24/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/18/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/13/2021 Patient Sequence Number: 1
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