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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 High impedance (1291)
Patient Problem Insufficient Information (4580)
Event Date 02/19/2021
Event Type  malfunction  
Event Description
It was reported that the health care professional found a red alert on this cardiac resynchronization therapy pacemaker (crt-p). The alert detected was for a high out-of-range (ooo) left ventricular (lv) lead pacing impedances. It was noted a couple months ago the impedances have been rising intermittently measuring as high as 1424 ohms. Boston scientific technical services (ts) discussed having the patient complete a patient initiated interrogation and bring in for clinic assessment. Ts recommended performing isometrics and pocket manipulation to see if noise is present or if they can get any measurements. The clinic check will reset the alert condition. At this time 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 Key11661608
MDR Text Key245514277
Report Number2124215-2021-05363
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,Followup
Report Date 06/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/09/2022
Device Model NumberU125
Device Catalogue NumberU125
Device Lot Number715238
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 Received04/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/12/2020
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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