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 Over-Sensing (1438); Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Presyncope (4410)

Event Date 08/26/2022

Event Type  Injury  

Manufacturer Narrative

Information indicates this device will be returned for analysis.This investigation will be updated should further information be provided.

Event Description

It was reported that this patient presented to the emergency room due to experiencing a near-syncope event.This cardiac resynchronization therapy pacemaker (crt-p) device was interrogated and found to have reverted to safety mode with limited critical therapy still available.Boston scientific technical services (ts) explained that device pacing and sensing settings are the unipolar configuration when in safety mode.It was noted that the device unipolar configuration most likely resulted in myopotential oversensing and pacing inhibition which caused the patients near-syncope symptoms.Ts suggested that the device be replaced as soon as possible.The patient was admitted to the hospital and prepared for a device replacement procedure.It was indicated that the physician elected to implant a temporary pacing wire before performing the device replacement.The device was then explanted and replaced the same day.The surgical procedure was noted to have been completed with no complications.No additional adverse patient effects were reported.

Manufacturer Narrative

Information indicates this device will be returned for analysis.This investigation will be updated should further information be provided.This correction supplemental report was submitted with a correction to the impact codes table in report section h6.

Event Description

It was reported that this patient presented to the emergency room due to experiencing a near-syncope event.This cardiac resynchronization therapy pacemaker (crt-p) device was interrogated and found to have reverted to safety mode with limited critical therapy still available.Boston scientific technical services (ts) explained that device pacing and sensing settings are the unipolar configuration when in safety mode.It was noted that the device unipolar configuration most likely resulted in myopotential oversensing and pacing inhibition which caused the patients near-syncope symptoms.Ts suggested that the device be replaced as soon as possible.The patient was admitted to the hospital and prepared for a device replacement procedure.It was indicated that the physician elected to implant a temporary pacing wire before performing the device replacement.The device was then explanted and replaced the same day.The surgical procedure was noted to have been completed with no complications.No additional adverse patient effects were reported.

Manufacturer Narrative

Information indicates this device will be returned for analysis.This investigation will be updated should further information be provided.This correction supplemental report was submitted with a correction to the impact codes table in report section h6.This device was thoroughly inspected and analyzed upon receipt at our quality assurance laboratory.The device case was removed to facilitate inspection of the internal components and further testing.The battery was removed from the device and replaced with an external power source.The current drain was measured and found to be normal.Detailed analysis of the battery identified an internal short, which was caused by a tear in the cathode insulating tube.The short caused an increase in power consumption, which resulted in the clinically-observed reversion to safety mode operation.

Event Description

It was reported that this patient presented to the emergency room due to experiencing a near-syncope event.This cardiac resynchronization therapy pacemaker (crt-p) device was interrogated and found to have reverted to safety mode with limited critical therapy still available.Boston scientific technical services (ts) explained that device pacing and sensing settings are the unipolar configuration when in safety mode.It was noted that the device unipolar configuration most likely resulted in myopotential oversensing and pacing inhibition which caused the patients near-syncope symptoms.Ts suggested that the device be replaced as soon as possible.The patient was admitted to the hospital and prepared for a device replacement procedure.It was indicated that the physician elected to implant a temporary pacing wire before performing the device replacement.The device was then explanted and replaced the same day.The surgical procedure was noted to have been completed with no complications.No additional 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: 15331002
• MDR Text Key: 299036977
• Report Number: 2124215-2022-33604
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/17/2017
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 702143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 89 YR
• Patient Sex: Female