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

Model Number U128

Device Problems Signal Artifact/Noise (1036); Failure to Capture (1081); High impedance (1291); Over-Sensing (1438); Connection Problem (2900)

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

Event Date 07/30/2022

Event Type  malfunction  

Event Description

It was reported that the right atrial (ra) lead exhibited high, out-of-range pacing impedance of greater than 3000 ohms, causing a lead safety switch (lss) from a bipolar to a unipolar configuration.Boston scientific technical services (ts) was contacted, and ts noted that a signal artifact monitor (sam) event had occurred the day before due to variable impedances.Ts discussed possible causes for the high impedances, and because the implant was so recent a connection issue was suspected.The device and leads remain in service.No adverse patient effects were reported.

Event Description

It was reported that the right atrial (ra) lead exhibited high, out-of-range pacing impedance of greater than 3000 ohms, causing a lead safety switch (lss) from a bipolar to a unipolar configuration.Boston scientific technical services (ts) was contacted, and ts noted that a signal artifact monitor (sam) event had occurred the day before due to variable impedances.Ts discussed possible causes for the high impedances, and because the implant was so recent a connection issue was suspected.The device and leads remain in service.No adverse patient effects were reported.Ts was later contacted again regarding the aforementioned sam episode which was believed to be due to the high ra impedance.Noise on the ra channel was also noted, but could not be recreated in the clinic.In clinic testing revealed ra non-capture in the bipolar configuration.Ts discussed programming changes.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Investigation of the available information determined this device exhibited oversensing of noise generated by the minute ventilation (mv) that is related to intermittent increases in impedance measurements.Engineering analysis and testing of returned products has identified that any repeated, small movements of the lead terminal ring can create wearing of the lead terminal ring and generate microscopic particles, which may accumulate and oxidize over time.This can impact the connection between the spring contact and the lead ring, resulting in intermittent changes in impedance measurements.Please refer to the description field for more information regarding the specific circumstances of this event.This device was included in the minute ventilation sensor signal oversensing advisory population.

Event Description

It was reported that the right atrial (ra) lead exhibited high, out-of-range pacing impedance of greater than 3000 ohms, causing a lead safety switch (lss) from a bipolar to a unipolar configuration.Boston scientific technical services (ts) was contacted, and ts noted that a signal artifact monitor (sam) event had occurred the day before due to variable impedances.Ts discussed possible causes for the high impedances, and because the implant was so recent a connection issue was suspected.The device and leads remain in service.No adverse patient effects were reported.Ts was later contacted again regarding the aforementioned sam episode which was believed to be due to the high ra impedance.Noise on the ra channel was also noted, but could not be recreated in the clinic.In clinic testing revealed ra non-capture in the bipolar configuration.Ts discussed programming changes.

• Brand Name: VALITUDE X4 CRT-P
• Type of Device: IMPLANTABLE DEVICE
• 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: 15162533
• MDR Text Key: 297235587
• Report Number: 2124215-2022-28976
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/28/2023
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 764392
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0361-2018
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Male