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

Model Number U125

Device Problems Failure to Capture (1081); High impedance (1291); Over-Sensing (1438); High Capture Threshold (3266)

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

Event Date 06/25/2020

Event Type  malfunction  

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) exhibited high out of range pacing impedances measuring greater than 2000 ohms with this other manufactures left ventricular (lv) lead in which triggered a lead safety switch (lss).It was also noted there was a rise in right atrial (ra) lead impedances that still remained within range, and the device minute ventilation sensor was oversensing the change in impedances causing a stored signal artifact monitoring (sam) episode that switched sensing vectors.Technical services discussed programming options and possible causes.Technical services also suggested to evaluate the lv thresholds as the presenting electrocardiogram may show loss of capture.At this time, this crt-p and the other manufactures leads 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)/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) exhibited high out of range pacing impedances measuring greater than 2000 ohms with this other manufactures left ventricular (lv) lead in which triggered a lead safety switch (lss).It was also noted there was a rise in right atrial (ra) lead impedances that still remained within range, and the device minute ventilation sensor was oversensing the change in impedances causing a stored signal artifact monitoring (sam) episode that switched sensing vectors.Technical services discussed programming options and possible causes.Technical services also suggested to evaluate the lv thresholds as the presenting electrocardiogram may show loss of capture.At this time, this crt-p and the other manufactures leads remains in service.No adverse patient effects were reported.

• Brand Name: VALITUDE CRT-P
• Type of Device: IMPLANTABLE DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 10606489
• MDR Text Key: 209177030
• Report Number: 2124215-2020-15194
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559389
• UDI-Public: 00802526559389
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 09/30/2020

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: 08/16/2021
• Device Model Number: U125
• Device Catalogue Number: U125
• Device Lot Number: 714213
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/22/2020
• Initial Date FDA Received: 09/30/2020
• Supplement Dates Manufacturer Received: 07/22/2020
• Supplement Dates FDA Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0358-2018
• Patient Sequence Number: 1
• Patient Age: 1 YR