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

Model Number U128

Device Problems Over-Sensing (1438); Low impedance (2285)

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

Event Date 05/02/2019

Event Type  malfunction  

Manufacturer Narrative

This device was included in the recent minute ventilation sensor signal oversensing advisory population.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) device exhibited two (2) signal artifact monitor (sam) events on the same day due to noise and oversensing of the minute ventilation (mv) sensor.This resulted in the mv sensor being automatically disabled by the device.Review of electrograms indicated both events exhibited noise on both the right atrial (ra) and right ventricular (rv) channels.It was also noted that the rv lead exhibited a corresponding low out of range pace impedance measurement less than 200 ohms.The rv lead is not a boston scientific product.The daily impedance measurements were indicated to be stable.Boston scientific technical service (ts) recommended to the healthcare provider (hcp) to keep the rate response trend (rrt) feature programmed off.The products remain in-service.No patient symptoms or 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.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.Please see the description for more information regarding the specific circumstances of this event.This device was included in the recent minute ventilation sensor signal oversensing advisory population.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) device exhibited two (2) signal artifact monitor (sam) events on the same day due to noise and oversensing of the minute ventilation (mv) sensor.This resulted in the mv sensor being automatically disabled by the device.Review of electrograms indicated both events exhibited noise on both the right atrial (ra) and right ventricular (rv) channels.It was also noted that the rv lead exhibited a corresponding low out of range pace impedance measurement less than 200 ohms.The rv lead is not a boston scientific product.The daily impedance measurements were indicated to be stable.Boston scientific technical service (ts) recommended to the healthcare provider (hcp) to keep the rate response trend (rrt) feature programmed off.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
• MDR Report Key: 9947245
• MDR Text Key: 187232007
• Report Number: 2124215-2020-06061
• 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
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/17/2018
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 715237
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/07/2020
• Removal/Correction Number: Z-0361-2018
• Patient Sequence Number: 1
• Patient Age: 91 YR