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); Failure to Capture (1081); High impedance (1291)

Patient Problems Device Overstimulation of Tissue (1991); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/02/2022

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) exhibited high out of range pace impedance measurements on the left ventricular (lv) lead.Boston scientific technical services (ts) was consulted and recommended further testing to evaluate this lead's position.No adverse patient effects were reported.At this time, this device system remains in service.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) exhibited high out of range pace impedance measurements on the left ventricular (lv) lead.Boston scientific technical services (ts) was consulted and recommended further testing to evaluate this lead's position.No adverse patient effects were reported.At this time, this device system remains in service.Additional information was received that the lv lead exhibited loss of capture (loc) as well.A lead revision was performed and this lead was explanted and replaced.Shortly after the implant procedure, the patient experienced diaphragmatic stimulation and upon a device check, out of range impedance measurements were noted again.During a follow up the next morning, the field representative noted a safety switch had occurred and noise was also observed.Ts was consulted and noted the power consumption of this device has been increasing shortly after implant.A request was made to have data from this device analyzed.Data analysis confirmed a malfunction of the lv pace channel.These lead results in tandem with abnormally high power consumption is consistent with a malfunction of the analog ic within the device.Device replacement was recommended.The field representative stated this will be discussed with the following physician.Additional information was received that this device has been explanted and replaced.No additional adverse patient effects were reported.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) exhibited high out of range pace impedance measurements on the left ventricular (lv) lead.Boston scientific technical services (ts) was consulted and recommended further testing to evaluate this lead's position.No adverse patient effects were reported.At this time, this device system remains in service.Additional information was received that the lv lead exhibited loss of capture (loc) as well.A lead revision was performed and this lead was explanted and replaced.Shortly after the implant procedure, the patient experienced diaphragmatic stimulation and upon a device check, out of range impedance measurements were noted again.During a follow up the next morning, the field representative noted a safety switch had occurred and noise was also observed.Ts was consulted and noted the power consumption of this device has been increasing shortly after implant.A request was made to have data from this device analyzed.Data analysis confirmed a malfunction of the lv pace channel.These lead results in tandem with abnormally high power consumption is consistent with a malfunction of the analog ic within the device.Device replacement was recommended.The field representative stated this will be discussed with the following physician.The device remains in service and there is no evidence to suggest a device replacement procedure has been scheduled at this time.No additional adverse patient effects were reported.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) exhibited high out of range pace impedance measurements on the left ventricular (lv) lead.Boston scientific technical services (ts) was consulted and recommended further testing to evaluate this lead's position.No adverse patient effects were reported.At this time, this device system remains in service.Additional information was received that the lv lead exhibited loss of capture (loc) as well.A lead revision was performed and this lead was explanted and replaced.Shortly after the implant procedure, the patient experienced diaphragmatic stimulation and upon a device check, out of range impedance measurements were noted again.During a follow up the next morning, the field representative noted a safety switch had occurred and noise was also observed.Ts was consulted and noted the power consumption of this device has been increasing shortly after implant.A request was made to have data from this device analyzed.Data analysis confirmed a malfunction of the lv pace channel.These lead results in tandem with abnormally high power consumption is consistent with a malfunction of the analog ic within the device.Device replacement was recommended.The field representative stated this will be discussed with the following physician.Additional information was received that this device has been explanted and replaced.No additional adverse patient effects were reported.This device has been received for analysis.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the product was performed.Review of device memory confirmed the presence of a higher-than-normal current drain condition.Electrical testing and analysis were then conducted, which isolated the high current to an anomaly in an oxide layer within a custom ic component.This anomaly caused a high current drain and, over time, resulted in the reported clinical observations.

• 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: 15814707
• MDR Text Key: 305158613
• Report Number: 2124215-2022-47656
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 775387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2022
• 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: 75 YR
• Patient Sex: Female