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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 High impedance (1291); High Capture Threshold (3266)
Patient Problem Insufficient Information (4580)
Event Date 04/01/2021
Event Type  malfunction  
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) and non-boston scientific left ventricular (lv) lead exhibited high out-of-range (oor) pacing impedances measuring greater than 2000 ohms. A lead safety switch (lss) was also declared which switched the pace/sense configuration from bipolar to unipolar. Troubleshooting was performed and when programmed tip to ring impedances were still oor. Additionally, thresholds have increased. Isometric testing was performed and there was no observations of noise. Technical services recommended programming options. At this time, the crt-d and non-boston scientific lv lead remains in service. No 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 Key12114312
MDR Text Key260030060
Report Number2124215-2021-16650
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 health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberU128
Device Catalogue NumberU128
Device Lot Number751206
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/06/2020
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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