MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VALITUDE X4 CRT-P; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

Model Number U128

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Low impedance (2285)

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

Event Date 09/05/2020

Event Type  malfunction  

Event Description

It was reported that noise was observed on both right atrial (ra) and right ventricular (rv) channels of this cardiac resynchronization therapy pacemaker (crt-p) device.The noise was unable to reproduced in the clinic and lead impedances are normal and stable.A specific stored atrial tachycardia response (atr) episode shows approximately five seconds of noise on both channels.The ra lead is oversensing the noise but still shows proper p-waves.The rv lead only had one oversensed artifact which extended one v-v interval but most of the noise is not sensed on the rv lead.The ra and rv leads are not boston scientific products.It was noted that noise is seen on various dates and boston scientific technical services (ts) suspects the noise is due to electromagnetic interference (emi).The healthcare provider (hcp) will continue to monitor.The device remains in-service.No patient symptoms or adverse patient effects were reported.Additional information was received that a different hcp from the same healthcare facility (hcf) contacted ts again approximately three years later indicating there continues to be noise observed on the ra and rv leads.The hcp indicated the crt-p device is eight months from explant status and wanted to review the noise issue again.The ra and rv leads are not boston scientific products.It was noted that the patient has been contacted and is not doing anything specific at the time the noise occurs.Ts reviewed rate counts and noted a large number of ra beats due to the patients ra rate of greater than 250 beats per minute.It was noted that sensitivity programming is the same as in 2020.Ts provided guidance to the hcp to consider measuring the noise amplitude with a programmer and if possible, adjust the ra sensitivity.Ts also stated they should be aggressive in arm movement and isometric testing.Ts indicated it is possible myopotential noise or some sort of lead insulation problem, but it does not seem to be emi.In addition, ts noted a slight decrease in ra lead pace impedance measurements into the mid-300 ohms range, which is low but still within normal specification limits.Ts stated they should measure impedances in the presence of noise.It was indicated that the plan is to see the patient in the clinic the next day.The products remain in-service.No patient symptoms or adverse patient effects were reported.

• Brand Name: VALITUDE X4 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: 18284123
• MDR Text Key: 329954545
• Report Number: 2124215-2023-69549
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/22/2016
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 100553
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Sex: Male