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

Model Number U125

Device Problems Signal Artifact/Noise (1036); Failure to Capture (1081); High impedance (1291); Over-Sensing (1438); Device Sensing Problem (2917)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/19/2021

Event Type  malfunction  

Event Description

It was reported that the health care professional found a red alert on this cardiac resynchronization therapy pacemaker (crt-p).The alert detected was for a high out-of-range (ooo) left ventricular (lv) lead pacing impedances.It was noted a couple months ago the impedances have been rising intermittently measuring as high as 1424 ohms.Boston scientific technical services (ts) discussed having the patient complete a patient initiated interrogation and bring in for clinic assessment.Ts recommended performing isometrics and pocket manipulation to see if noise is present or if they can get any measurements.The clinic check will reset the alert condition.At this time this crt-p and lv lead remains in service.No 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 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 the health care professional found a red alert on this cardiac resynchronization therapy pacemaker (crt-p).The alert detected was for a high out-of-range (ooo) left ventricular (lv) lead pacing impedances.It was noted a couple months ago the impedances have been rising intermittently measuring as high as 1424 ohms.Boston scientific technical services (ts) discussed having the patient complete a patient initiated interrogation and bring in for clinic assessment.Ts recommended performing isometrics and pocket manipulation to see if noise is present or if they can get any ooo measurements.The clinic check will reset the alert condition.At this time this crt-p and lv lead remains in service.No 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 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 the health care professional found a red alert on this cardiac resynchronization therapy pacemaker (crt-p).The alert detected was for a high out-of-range (ooo) left ventricular (lv) lead pacing impedances.It was noted a couple months ago the impedances have been rising intermittently measuring as high as 1424 ohms.Boston scientific technical services (ts) discussed having the patient complete a patient-initiated interrogation and bring in for clinic assessment.Ts recommended performing isometrics and pocket manipulation to see if noise is present or if they can get any ooo measurements.The clinic check will reset the alert condition.At this time this crt-p and lv lead remains in service.No adverse patient effects were reported.This supplemental report is being filed as additional information was received that reported this left ventricular (lv) lead exhibited fluctuating thresholds and has intermittent loss of capture.Additionally, there were some noise signals on the presenting electrogram (egm) that appear to be non-physiologic.At this time, the cardiac resynchronization therapy pacemaker (crt-p) system remains in service.No adverse patient effects were reported.

Event Description

It was reported that the health care professional found a red alert on this cardiac resynchronization therapy pacemaker (crt-p).The alert detected was for a high out-of-range (ooo) left ventricular (lv) lead pacing impedances.It was noted a couple months ago the impedances have been rising intermittently measuring as high as 1424 ohms.Boston scientific technical services (ts) discussed having the patient complete a patient-initiated interrogation and bring in for clinic assessment.Ts recommended performing isometrics and pocket manipulation to see if noise is present or if they can get any ooo measurements.The clinic check will reset the alert condition.At this time this crt-p and lv lead remains in service.No adverse patient effects were reported.This supplemental report is being filed as additional information was received that reported this left ventricular (lv) lead exhibited fluctuating thresholds and has intermittent loss of capture.Additionally, there were some noise signals on the presenting electrogram (egm) that appear to be non-physiologic.At this time, the cardiac resynchronization therapy pacemaker (crt-p) system remains in service.No adverse patient effects were reported.Additional information was received which reported this device exhibited left ventricular (lv) noise that was being oversensed.At this time, the system remains in service.No 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 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.

• Brand Name: VALITUDE 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: 11661608
• MDR Text Key: 245514277
• Report Number: 2124215-2021-05363
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559389
• UDI-Public: 00802526559389
• 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,Followup
• Report Date: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/09/2022
• Device Model Number: U125
• Device Catalogue Number: U125
• Device Lot Number: 715238
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2020
• 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: 42 YR
• Patient Sex: Male