MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VALITUDE CRT-P PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

Model Number U125

Device Problems Failure to Capture (1081); High impedance (1291)

Patient Problem Dizziness (2194)

Event Date 09/19/2019

Event Type  malfunction  

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted. The associated investigation determined that this device exhibited intermittent impedance measurements with no conclusive evidence of a malfunction or inadequate lead-to-device connection; please refer to the description for more information regarding the specific circumstances of this event.

Event Description

It was reported that this patient experienced a near syncopal event and data review noted non capture. However, there appears to be dual pacing spikes at a rate of 100ppm and the patient's underlying rhythm is approximately 40bpm. A boston scientific technical services consultant stated that if there is pacing then there is no capture. The consultant reviewed the data that was collected today. There is variable impedance measurements on all channels with no out of range measurements observed. It appears that signal artifact monitoring (sam) had disabled the respiratory rate trend (rrt); however, there was no stored episode. It was noted that the patient is in chronic atrial fibrillation (af) but atrial sensing is still programmed on. The caller was not able to reproduce any issues during in office testing and reprogramming was performed to unipolar pacing and bipolar sensing. The consultant recommended further evaluation of the system. No adverse patient effects were reported.

• Brand Name: VALITUDE CRT-P
• Type of Device: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
• 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: 9666457
• MDR Text Key: 177766154
• Report Number: 2124215-2020-02483
• 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: company representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 02/04/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/04/2018
• Device Model Number: U125
• Device Catalogue Number: U125
• Device Lot Number: 702564
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial