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); Pacing Problem (1439); Under-Sensing (1661); Device Sensing Problem (2917)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/28/2018

Event Type  Injury  

Manufacturer Narrative

The device has not been returned at this time.If the device is returned, analysis will be performed and this report will be updated.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) and non boston scientific right ventricular (rv) lead exhibited noise, oversensing, increased impedance measurements which were not out of range, and pacing inhibition with approximately six to ten seconds of asystole.The rv noise appeared to be from minute ventilation (mv) signals.Also, the device and a non boston scientific right atrial (ra) lead exhibited ra impedance measurements of greater than 3000 ohms, and a lead safety switch.Then ra noise and oversensing were noted after this due to unipolar sensing.The noise resulted in undersensing of the patients chronic atrial fibrillation (af).The device and leads were explanted and replaced.No additional adverse patient effects were reported.

Event Description

This report is being filed to provide product investigation results.

Manufacturer Narrative

The returned device was analyzed.A visual inspection of the device header and case noted no anomalies.Pin gauge 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.

Event Description

This report is being filed to update evaluation coding.

Manufacturer Narrative

This device was included in the recent minute ventilation sensor signal oversensing advisory population.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)/respiratory sensor that is related to a high impedance condition.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 see the description for more information regarding the specific circumstances of this event.

• 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
• MDR Report Key: 9540577
• MDR Text Key: 173388080
• Report Number: 2124215-2019-22772
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559402
• UDI-Public: 00802526559402
• Combination Product (y/n): N
• PMA/PMN Number: P030005/S113
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/07/2019
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 720153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Date Manufacturer Received: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-3258-2018
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 89 YR