MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VALITUDE X4 CRT-P; IMPLANTABLE PACEMAKER

Model Number U128

Device Problems False Positive Result (1227); Over-Sensing (1438); Low impedance (2285)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/17/2022

Event Type  malfunction  

Event Description

It was reported that this implantable pacemaker recorded a signal automatic monitoring (sam) episode due to an intrinsic atrial fibrillation episode experienced by the patient.Due to this, the minute ventilation (mv) sensor was disabled.Furthermore, low out of range pacing impedance measurements were exhibited from both the right ventricular and right atrial channels.Troubleshooting options were discussed.This device remains in service.No further adverse patient effects were reported.

Manufacturer Narrative

Additional information was added to the following fields: h6: device codes.

Event Description

It was reported that this implantable pacemaker recorded a signal automatic monitoring (sam) episode due to an intrinsic atrial fibrillation episode experienced by the patient.Due to this, the minute ventilation (mv) sensor was disabled.Furthermore, low out of range pacing impedance measurements were exhibited from both the right ventricular and right atrial channels.Troubleshooting options were discussed.This device remains in service.No further adverse patient effects were reported.

• Brand Name: VALITUDE X4 CRT-P
• Type of Device: IMPLANTABLE PACEMAKER
• 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: 14682640
• MDR Text Key: 293936532
• Report Number: 2124215-2022-21083
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559402
• UDI-Public: 00802526559402
• 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: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/29/2021
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 748754
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2022
• Initial Date FDA Received: 06/13/2022
• Supplement Dates Manufacturer Received: 06/06/2022
• Supplement Dates FDA Received: 06/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2019
• 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: 59 YR
• Patient Sex: Male