MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VALITUDE X4 CRT-P; IMPLANTABLE PACEMAKER

Model Number U128

Device Problems High impedance (1291); Incorrect, Inadequate or Imprecise Result or Readings (1535); High Capture Threshold (3266)

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

Event Date 03/03/2022

Event Type  Injury  

Event Description

It was reported that this implantable pacemaker entered in safety mode due to high out of range impedance measurements on the right atrial channel.Furthermore, high pacing thresholds were observed on the right atrial and right ventricular channel.This device was replaced and is expected to be returned for analysis.No further adverse patient effects were reported.

Manufacturer Narrative

The returned device was inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Analysis of the memory of the device was performed and it was determined that a memory corruption was present on the device which prevented the usual memory dump tools from operating.Additionally, a series of diagnostic tests were conducted that verified the performance of pacing and sensing functions.Having met the engineering longevity prediction, functionally passed all returned product testing it was concluded we have concluded that this device experienced normal battery depletion.The associated investigation determined that this device exhibited intermittent impedance measurements with no conclusive evidence of a malfunction or inadequate lead-to-device connection; please refer to the complaint description for more information regarding the specific circumstances of this event.Investigation has determined that this type of event is likely the result of an intermittent high impedance condition associated with the device spring contact and lead terminal ring.A design enhancement was implemented in 2020 to stabilize the electrical connection between the spring contact and the lead terminal.

Event Description

It was reported that this implantable pacemaker entered in safety mode due to high out of range impedance measurements on the right atrial channel.Furthermore, high pacing thresholds were observed on the right atrial and right ventricular channel.This device was replaced and is expected to be returned for analysis.No further adverse patient effects were reported.

Manufacturer Narrative

The returned device was inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Analysis of the memory of the device was performed and it was determined that a memory corruption was present on the device which prevented the usual memory dump tools from operating.Additionally, a series of diagnostic tests were conducted that verified the performance of pacing and sensing functions.Having met the engineering longevity prediction, functionally passed all returned product testing it was concluded we have concluded that this device experienced normal battery depletion.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.Additionally, a series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.The associated investigation also determined that this device exhibited intermittent impedance measurements with no conclusive evidence of a malfunction or inadequate lead-to-device connection.

Event Description

It was reported that this implantable pacemaker entered in safety mode due to high out of range impedance measurements on the right atrial channel.Furthermore, high pacing thresholds were observed on the right atrial and right ventricular channel.This device was replaced and is expected to be returned for analysis.No further adverse patient effects were reported.

Manufacturer Narrative

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 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.Additionally, pin gage testing, designed to verify proper port dimensions, was completed.Each port measured as expected.The device was then exposed to simulated heart load conditions, and the pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.The associated investigation also determined that this device exhibited intermittent impedance measurements with no conclusive evidence of a product performance issue or inadequate lead-to-device connection.

Event Description

It was reported that this implantable pacemaker entered in safety mode due to high out of range impedance measurements on the right atrial channel.Furthermore, high pacing thresholds were observed on the right atrial and right ventricular channel.This device was replaced and is expected to be returned for analysis.No further adverse patient effects were reported.

• Brand Name: VALITUDE X4 CRT-P
• Type of Device: IMPLANTABLE PACEMAKER
• 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: 14504729
• MDR Text Key: 292700861
• Report Number: 2124215-2022-13520
• Device Sequence Number: 1
• Product Code: NKE
• 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: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/19/2018
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 714127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2016
• 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: 64 YR
• Patient Sex: Male