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

Model Number U128

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

Patient Problem Asystole (4442)

Event Date 10/28/2023

Event Type  Injury  

Event Description

It was reported that this implantable pacemaker exhibited noise, oversensing and pacing inhibition on the right ventricular channel.Additionally, the pacing impedance measurements are also trending down on the right ventricular channel.A lead fracture is suspected; however, it has not been confirmed.Reprograming of the device was discussed.This device remains in service.No further adverse patient effects were reported.

Manufacturer Narrative

Additional information was added to the following fields: b1: adverse event/product problem b2: outcome attributed to adverse event b5: describe event or problem field d6b: explant date h1: type of reportable event h6: impact codes.

Event Description

It was reported that this implantable pacemaker exhibited noise, oversensing and pacing inhibition on the right ventricular channel.Additionally, the pacing impedance measurements are also trending down on the right ventricular channel.A lead fracture is suspected; however, it has not been confirmed.Reprograming of the device was discussed.This device remains in service.No further adverse patient effects were reported.Additional information was received detailing that this device was explanted and replaced.This device is expected to be returned for analysis.

Manufacturer Narrative

The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Dimensional analysis of the header was completed.Each port measured as expected.The device was then exposed to simulated heart load conditions, and the pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.

Event Description

It was reported that this implantable pacemaker exhibited noise, oversensing and pacing inhibition on the right ventricular channel.Additionally, the pacing impedance measurements are also trending down on the right ventricular channel.A lead fracture is suspected; however, it has not been confirmed.Reprograming of the device was discussed.This device remains in service.No further adverse patient effects were reported.Additional information was received detailing that this device was explanted and replaced.This device is expected to be returned for analysis.

• 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: 18210217
• MDR Text Key: 329026100
• Report Number: 2124215-2023-66841
• 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,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/19/2019
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 720570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2017
• 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 Outcome(s): Required Intervention; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Male