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); Pacing Problem (1439)

Patient Problems No Known Impact Or Consequence To Patient (2692); Asystole (4442)

Event Date 07/09/2020

Event Type  malfunction  

Event Description

It was reported that this device exhibited high out-of-range pacing impedances on the non-boston scientific right ventricular (rv) lead, measuring greater than 2000 ohms.Boston scientific technical services (ts) was asked for a consult and noted several instances of out of range measurements as well as pacing inhibition for 3.5 seconds due to myopotential oversensing.Ts recommended bringing the patient in to evaluate the rv lead.The device remains in service.The patient is pacing dependent.No additional adverse patient effects were reported.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.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 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's 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 device exhibited high out-of-range pacing impedances on the non-boston scientific right ventricular (rv) lead, measuring greater than 2000 ohms.Boston scientific technical services (ts) was asked for a consult and noted several instances of out of range measurements as well as pacing inhibition for 3.5 seconds due to myopotential oversensing.Ts recommended bringing the patient in to evaluate the rv lead.The device remains in service.The patient is pacing dependent.No additional adverse patient effects were reported.

Event Description

It was reported that this device exhibited high out-of-range pacing impedances on the non-boston scientific right ventricular (rv) lead, measuring greater than 2000 ohms.Boston scientific technical services (ts) was asked for a consult and noted several instances of out of range measurements as well as pacing inhibition for 3.5 seconds due to myopotential oversensing.Ts recommended bringing the patient in to evaluate the rv lead.The device remains in service.The patient is pacing dependent.No additional adverse patient effects were reported.Additional information was received indicating the non-boston scientific rv lead was exhibiting high, out-of-range pace impedance measurements of greater than 3000 ohms.Loss of capture (loc) with four second pauses and asystole were also reported, and so the health care professional (hcp) reprogrammed the device, increasing pacing outputs.Ts was contacted, and ts discussed programming options.The device remains in service.No additional adverse patient effects were reported.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.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 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's 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 device exhibited high out-of-range pacing impedances on the non-boston scientific right ventricular (rv) lead, measuring greater than 2000 ohms.Boston scientific technical services (ts) was asked for a consult and noted several instances of out of range measurements as well as pacing inhibition for 3.5 seconds due to myopotential oversensing.Ts recommended bringing the patient in to evaluate the rv lead.The device remains in service.The patient is pacing dependent.No additional adverse patient effects were reported.Additional information was received indicating the non-boston scientific rv lead was exhibiting high, out-of-range pace impedance measurements of greater than 3000 ohms.Loss of capture (loc) with four second pauses and asystole were also reported, and so the health care professional (hcp) reprogrammed the device, increasing pacing outputs.Ts was contacted, and ts discussed programming options.The device remains in service.No additional adverse patient effects were reported.Additional information was received indicating the device was explanted and replaced due to normal battery depletion.No adverse patient effects were reported.

Manufacturer Narrative

The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.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.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.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.

• 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: 10620262
• MDR Text Key: 209599702
• Report Number: 2124215-2020-16689
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/02/2017
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 703921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2015
• 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 Age: 85 YR
• Patient Sex: Male