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); Under-Sensing (1661)

Patient Problems Bradycardia (1751); Fall (1848)

Event Date 08/10/2023

Event Type  Injury  

Event Description

It was reported that this non pacemaker dependent patients device displayed safety mode.This patient presented to the emergency room (er) after experiencing a fall.Later findings noted this was due to oversensing of myopotentials resulting in pacing inhibition with pauses in pacing up to 10 seconds.This patient was to undergo a change out procure.While this patient was slid into the x ray table, this device undersensed and did not pace at the safety mode rate.This patient received cardiopulmonary resuscitations for approximately 30 seconds and then recovered.This patient received a temporary pacemaker prior to change out.This device was successfully explanted and replaced with a new device, which remains in service.No additional adverse patient effects were reported.

Manufacturer Narrative

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

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Interrogation of the device confirmed it was operating in safety mode and that bradycardia therapy remained available.Engineers determined that this device was demonstrating behavior consistent with a high internal cell impedance within the battery.The high internal impedance put this device at risk of experiencing transient voltage decreases (and associated resets) during periods of high-power consumption.When battery voltage drops below a minimum threshold, a system reset is performed.If three system resets occur within a 48-hour period, the device is designed to immediately enter safety mode operation to maintain back-up pacing with pre-defined, non-programmable settings.

Event Description

It was reported that this non pacemaker dependent patients device displayed safety mode.This patient presented to the emergency room (er) after experiencing a fall.Later findings noted this was due to oversensing of myopotentials resulting in pacing inhibition with pauses in pacing up to 10 seconds.This patient was to undergo a change out procure.While this patient was slid into the x ray table, this device undersensed and did not pace at the safety mode rate.This patient received cardiopulmonary resuscitations for approximately 30 seconds and then recovered.This patient received a temporary pacemaker prior to change out.This device was successfully explanted and replaced with a new device, which remains in service.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: 17563771
• MDR Text Key: 321326013
• Report Number: 2124215-2023-44146
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/18/2019
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 723373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2023
• Initial Date FDA Received: 08/17/2023
• Supplement Dates Manufacturer Received: 10/31/2023
• Supplement Dates FDA Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male