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

Model Number U125

Device Problems Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438)

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

Event Date 03/01/2022

Event Type  malfunction  

Event Description

It was reported that the non-boston scientific right atrial lead exhibited noise and high, out-of-range pace impedance of greater than 2000 ohms which resulted in a lead safety switch (lss).There was also a signal artifact monitor (sam) event due to minute ventilation (mv) oversensing as a result of the lss.Boston scientific technical services (ts) was contacted, and ts discussed options.The device and leads remain 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.

Event Description

It was reported that the non-boston scientific right atrial lead exhibited noise and high, out-of-range pace impedance of greater than 2000 ohms which resulted in a lead safety switch (lss).There was also a signal artifact monitor (sam) event due to minute ventilation (mv) oversensing as a result of the lss.Boston scientific technical services (ts) was contacted, and ts discussed options.The device and leads remain 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.

Event Description

It was reported that the non-boston scientific right atrial lead exhibited noise and high, out-of-range pace impedance of greater than 2000 ohms which resulted in a lead safety switch (lss).There was also a signal artifact monitor (sam) event due to minute ventilation (mv) oversensing as a result of the lss.Boston scientific technical services (ts) was contacted, and ts discussed options.The device and leads remain in service.No adverse patient effects were reported.A second lss later occurred due to the out-of-range impedances three months later.

• 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: 14068655
• MDR Text Key: 288987986
• Report Number: 2124215-2022-09660
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/14/2022

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: 02/19/2021
• Device Model Number: U125
• Device Catalogue Number: U125
• Device Lot Number: 712210
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/08/2022
• Initial Date FDA Received: 04/09/2022
• Supplement Dates Manufacturer Received: 05/02/2022; 05/28/2022
• Supplement Dates FDA Received: 06/01/2022; 06/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2019
• 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: 88 YR
• Patient Sex: Female