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

Model Number U128

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 09/07/2022

Event Type  Injury  

Manufacturer Narrative

Information indicates this device is currently in the possession of the explanting hospital.This investigation will be updated should further information be provided.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) device reverted to safety mode with limited critical therapy still available.Boston scientific technical services (ts) discussed the details of safety mode with the healthcare provider (hcp) and explained the device pacing parameters when in safety mode, specifically unipolar right ventricular sensing with an automatic gain control sensing method.Ts recommended replacing the device soon.The device was subsequently explanted and replaced two days later.No additional adverse patient effects were reported.

Manufacturer Narrative

Information indicates this device is currently in the possession of the explanting hospital.This investigation will be updated should further information be provided.Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Visual examination of the device noted no anomalies.Interrogation of the device confirmed it was operating in safety mode.It was also confirmed that brady therapy remained available.The titanium case was opened, and the battery was removed so that an external power supply could be connected to the device circuitry for further analysis.The analysis indicated the device circuitry exhibited appropriate current and impedance measurements.The battery analysis indicated appropriate voltage and current measurements and normal function with no failure found.The results of the device analysis confirm the clinical observation, but the root cause of the failure could not be confirmed.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) device reverted to safety mode with limited critical therapy still available.Boston scientific technical services (ts) discussed the details of safety mode with the healthcare provider (hcp) and explained the device pacing parameters when in safety mode, specifically unipolar right ventricular sensing with an automatic gain control sensing method.Ts recommended replacing the device soon.The device was subsequently explanted and replaced two days later.No additional adverse patient effects were reported.

Manufacturer Narrative

Information indicates this device is currently in the possession of the explanting hospital.This investigation will be updated should further information be provided.Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Visual examination of the device noted no anomalies.Interrogation of the device confirmed it was operating in safety mode.It was also confirmed that brady therapy remained available.The titanium case was opened, and the battery was removed so that an external power supply could be connected to the device circuitry for further analysis.The analysis indicated the device circuitry exhibited appropriate current and impedance measurements.The battery analysis indicated appropriate voltage and current measurements and normal function with no failure found.The results of the device analysis confirm the clinical observation, but the root cause of the failure could not be confirmed.This additional supplemental report was submitted with updated device analysis conclusion.Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Device telemetry data confirmed it was operating in safety mode/determined it had undergone resets and that bradycardia therapy remained available.The titanium case was opened, and the battery was removed so that an external power supply could be connected to the device circuitry for further analysis.The analysis indicated the device circuitry exhibited appropriate current and impedance measurements.The battery analysis was performed, and 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 cardiac resynchronization therapy pacemaker (crt-p) device reverted to safety mode with limited critical therapy still available.Boston scientific technical services (ts) discussed the details of safety mode with the healthcare provider (hcp) and explained the device pacing parameters when in safety mode, specifically unipolar right ventricular sensing with an automatic gain control sensing method.Ts recommended replacing the device soon.The device was subsequently explanted and replaced two days later.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: 15410606
• MDR Text Key: 299767627
• Report Number: 2124215-2022-35635
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/04/2017
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 703411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2015
• 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: 89 YR
• Patient Sex: Female