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

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.

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.

• Brand Name: VALITUDE CRT-P
• Type of Device: IMPLANTABLE DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 10775503
• Report Number: 2124215-2020-23104
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559402
• UDI-Public: 00802526559402
• Combination Product (y/n): N
• PMA/PMN Number: P030005/S113
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/28/2020
• Device Model Number: U125
• Device Catalogue Number: U125
• Device Lot Number: 708928
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Age: 60 YR