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

Model Number U128

Device Problems Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438); Ambient Noise Problem (2877); Impedance Problem (2950)

Patient Problems No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/03/2018

Event Type  malfunction  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

Boston scientific received information that noise was noted on the right ventricular (rv) lead channel of this cardiac resynchronization therapy pacemaker (crt-p) due to oversensing of the minute ventilation (mv) signal.The caller inquired as to whether the device was conditionally approved for a magnetic resonance imaging (mri) scan.Boston scientific technical services (ts) advised that it was not.Non-abrupt impedance shifts were noted.Ts recommended programming mv off and evaluating right atrial (ra) lead.Ts also recommended programming to optimize if no noise was noted.No adverse patient effects were reported.Remains in service.This device was included in the recent mv sensor signal oversensing advisory population.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) device exhibited a high out of range pace impedance measurement on the right atrial (ra) lead which triggered a lead safety switch (lss).As a result of the lss, the device automatically switched the ra lead from the bipolar to the unipolar pacing and sensing configuration.The ra lead is not a boston scientific product.Boston scientific technical services (ts) noted there were several high impedance measurement values going back approximately four months and explained to the healthcare provider (hcp) the potential mechanism with regards to the ra lead ring.Ts reminded the hcp that due to the lss, the ra lead is now in the unipolar sensing configuration which is why there are numerous false atrial tachy response (atr) episodes.Ts suggested brining the patient into the clinic, reprograming the ra lead to a unipolar pacing and bipolar sensing configuration and evaluating for phrenic nerve stimulation, impedance and threshold.Ts also noted that a device interrogation resets the impedance alert and it is possible to have an out of range unipolar impedance measurement in the future.The products remain in-service.No patient symptoms or adverse patient effects were reported.

Manufacturer Narrative

This correction supplemental report was submitted with a change to the patient code in the patient codes table, additional device codes in the device codes table, and a component code in the component codes table of report section h6.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) device exhibited a high out of range pace impedance measurement on the right atrial (ra) lead which triggered a lead safety switch (lss).As a result of the lss, the device automatically switched the ra lead from the bipolar to the unipolar pacing and sensing configuration.The ra lead is not a boston scientific product.Boston scientific technical services (ts) noted there were several high impedance measurement values going back approximately four months and explained to the healthcare provider (hcp) the potential mechanism with regards to the ra lead ring.Ts reminded the hcp that due to the lss, the ra lead is now in the unipolar sensing configuration which is why there are numerous false atrial tachy response (atr) episodes.Ts suggested bringing the patient into the clinic, reprograming the ra lead to a unipolar pacing and bipolar sensing configuration and evaluating for phrenic nerve stimulation, impedance and threshold.Ts also noted that a device interrogation resets the impedance alert and it is possible to have an out of range unipolar impedance measurement in the future.The products remain in-service.No patient symptoms or adverse patient effects were reported.

Manufacturer Narrative

This correction supplemental report was submitted with a change to the patient code in the patient codes table, additional device codes in the device codes table, and a component code in the component codes table of report section h6.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) sensor 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.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) device exhibited a high out of range pace impedance measurement on the right atrial (ra) lead which triggered a lead safety switch (lss).As a result of the lss, the device automatically switched the ra lead from the bipolar to the unipolar pacing and sensing configuration.The ra lead is not a boston scientific product.Boston scientific technical services (ts) noted there were several high impedance measurement values going back approximately four months and explained to the healthcare provider (hcp) the potential mechanism with regards to the ra lead ring.Ts reminded the hcp that due to the lss, the ra lead is now in the unipolar sensing configuration which is why there are numerous false atrial tachy response (atr) episodes.Ts suggested bringing the patient into the clinic, reprograming the ra lead to a unipolar pacing and bipolar sensing configuration and evaluating for phrenic nerve stimulation, impedance and threshold.Ts also noted that a device interrogation resets the impedance alert and it is possible to have an out of range unipolar impedance measurement in the future.The products remain in-service.No patient symptoms or adverse patient effects were reported.

• 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: 7979928
• MDR Text Key: 124174312
• Report Number: 2124215-2018-15640
• 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,Followup
• Report Date: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/24/2018
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 714312
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2016
• 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
• Treatment: 4087; 4671; 5076; K173; U128; 4087; 4671; 5076; K173; U128
• Patient Age: 81 YR
• Patient Sex: Male