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); High impedance (1291); Over-Sensing (1438); Pacing Problem (1439); High Capture Threshold (3266)

Patient Problem Asystole (4442)

Event Date 04/30/2022

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p), implanted with another manufacturer's right ventricular (rv) and right atrial (ra) leads, exhibited noise with oversensing following rv sensitivity reprogramming from 2.5mv to 5.0mv due to greater than two seconds of pacing inhibition.It was noted that the patient was pacer dependent.There was also a recent increase in rv pace impedance measurements from 400 to 600 ohms, and a corresponding increase in rv autothreshold from 1.2-1.4v up to 1.7-1.8v.This crt-p system remains in service.No additional adverse patient effects were reported.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p), implanted with another manufacturer's right ventricular (rv) and right atrial (ra) leads, exhibited noise with oversensing following rv sensitivity reprogramming from 2.5mv to 5.0mv due to greater than two seconds of pacing inhibition.It was noted that the patient was pacer dependent.There was also a recent increase in rv pace impedance measurements from 400 to 600 ohms, and a corresponding increase in rv autothreshold from 1.2-1.4v up to 1.7-1.8v.This crt-p system remains in service.No additional adverse patient effects were reported.Additional information received reported that this cardiac resynchronization therapy pacemaker (crt-p), implanted with another manufacturer's right ventricular (rv) and right atrial (ra) leads, does not appear to have exhibited noise since august 10th.Rv sensitivity was previously reprogramming from 2.5mv to 5.0mv, however the physician planned to change sensitivity to 10mv.There were still concerns about rv noise and pacing inhibition, and there was discussion about possible lead replacement as the patient is pacer dependent.This crt-p system remains in service at this time.No additional adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: 15307276
• MDR Text Key: 302859580
• Report Number: 2124215-2022-32870
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/04/2020
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 733389
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2018
• 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: 58 YR
• Patient Sex: Male