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

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.

• Brand Name: VALITUDE CRT-P
• Type of Device: IMPLANTABLE 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 Key: 11661608
• MDR Text Key: 245514277
• Report Number: 2124215-2021-05363
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030005/S113
• Number of Events Reported: 1
• 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 Received: 04/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/09/2022
• Device Model Number: U125
• Device Catalogue Number: U125
• Device Lot Number: 715238
• 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 Received: 04/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial