MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VALITUDE X4 CRT-P; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

Model Number U128

Device Problems High impedance (1291); Over-Sensing (1438)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/19/2021

Event Type  malfunction  

Manufacturer Narrative

If additional information is received, a supplemental report will be filed at that time.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker exhibited right atrial pace impedance measurements of greater than 3,000 ohms, noise and oversensing.It was noted that the noise had the appearance of minute ventilation (mv) oversensing.Two signal artifact monitor episodes resulting in the mv feature being disabled.Boston scientific technical services discussed troubleshooting options with the health care professional including further evaluation in the clinic.At this time the device remains in service.No adverse patient effects were reported.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker exhibited right atrial pace impedance measurements of greater than 3,000 ohms, noise and oversensing.It was noted that the noise had the appearance of minute ventilation (mv) oversensing.Two signal artifact monitor episodes resulting in the mv feature being disabled.Boston scientific technical services discussed troubleshooting options with the health care professional including further evaluation in the clinic.At this time the device 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.Investigation of the available information determined this device exhibited oversensing of noise generated by the minute ventilation (mv) 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.

• Brand Name: VALITUDE X4 CRT-P
• Type of Device: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
• 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: 12660934
• MDR Text Key: 277354863
• Report Number: 2124215-2021-30147
• 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
• Report Date: 12/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/14/2019
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 726845
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2021
• Initial Date FDA Received: 10/19/2021
• Supplement Dates Manufacturer Received: 11/02/2021
• Supplement Dates FDA Received: 12/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2017
• 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: 49 YR
• Patient Sex: Female