MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VALITUDE X4 CRT-P; CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P)

Model Number U128

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); Device Sensing Problem (2917)

Patient Problem Non specific EKG/ECG Changes (1817)

Event Date 06/07/2018

Event Type  malfunction  

Event Description

It was reported that this pacemaker system exhibited noise and oversensing on both the right atrial (ra) and right ventricular (rv) leads resulting in 4 seconds of asystole.The noise was able to be reproduced with isometrics in the bipolar configuration.The physician reprogrammed the device to fixed sensitivity, and the rv sensitivity was adjusted.Additionally, the programming for several of the blanking periods was adjusted.The patient had a remote follow up the following month and there were no new episodes containing noise.The physician plans to continue to monitor.This product remains in service.No adverse patient effects were reported.

Event Description

This supplemental report is being filed to provide the updated conclusion code based on trend analysis.

Manufacturer Narrative

The returned cardiac resynchronization therapy pacemaker (crt-p) was analyzed, and an engineering-level longevity prediction calculation was completed to assess the rate of battery depletion.Given the programmed parameters and other data stored within the memory of the device, the results of this calculation indicated that the actual rate of battery depletion fell within an acceptable range.Next, a series of diagnostic tests were conducted that verified the performance of pacing, sensing, defibrillation and recording functions.Having met the engineering longevity prediction, functionally passed all returned product testing, and with no further information to indicate a product performance issue, we have concluded that this device experienced normal battery depletion.

Event Description

It was reported that this pacemaker system exhibited noise and oversensing on both the right atrial (ra) and right ventricular (rv) leads resulting in 4 seconds of asystole.The noise was able to be reproduced with isometrics in the bipolar configuration.The physician reprogrammed the device to fixed sensitivity, and the rv sensitivity was adjusted.Additionally, the programming for several of the blanking periods was adjusted.The patient had a remote follow up the following month and there were no new episodes containing noise.The physician plans to continue to monitor.This product remains in service.No adverse patient effects were reported.Additional information received this device was explanted and successfully replaced due to normal battery depletion.The device is returned for analysis.

• Brand Name: VALITUDE X4 CRT-P
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (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: 8112663
• MDR Text Key: 128744300
• Report Number: 2124215-2018-61881
• 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: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/13/2018
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 708538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Female