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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 Problems Failure to Capture (1081); High impedance (1291)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/01/2020
Event Type  malfunction  
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) and left ventricular (lv) lead exhibited a gradual increase in pacing impedances over the last year and impedances were measuring greater than 3000 ohms. The health care professional was inquiring about episode on the electrogram and boston scientific technical services informed that it looked like left sided ventricular tachycardia (vt) as the lv sense is coming in first. It was undetermined if there was loss of capture since there was no shock channel. Technical services recommended to have the patient further evaluated. Additional information was requested from the boston scientific field representative however, no further information was obtained. This crt-p and lv lead remains in service. No adverse patient effects were reported.
 
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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 Key10775503
MDR Text Key214349930
Report Number2124215-2020-23104
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 health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/18/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/28/2020
Device Model NumberU125
Device Catalogue NumberU125
Device Lot Number708928
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 Received12/04/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/16/2018
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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