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

Model Number U128

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

Patient Problems No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)

Event Date 12/01/2020

Event Type  malfunction  

Event Description

It was reported that a signal artifact monitor episode was noted.Boston scientific technical services reviewed the stored information and it was determined the noise appeared consistent with minute ventilation sensor oversensing.High out of range right atrial (ra) lead impedance measurements were also noted for another manufacturer's lead and this cardiac resynchronization therapy pacemaker (crt-p).Ts discussed that the impedance measurements have been fluctuating over the last couple of months and suggested turning off the rate response trend feature on the crt-p it was thought that this was to do with slight movement of the lead in the header of the crt-p.The device and lead remain in service and 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.

Event Description

It was reported that a signal artifact monitor episode was noted.Boston scientific technical services reviewed the stored information and it was determined the noise appeared consistent with minute ventilation sensor oversensing.High out of range right atrial (ra) lead impedance measurements were also noted for another manufacturer's lead and this cardiac resynchronization therapy pacemaker (crt-p).Ts discussed that the impedance measurements have been fluctuating over the last couple of months and suggested turning off the rate response trend feature on the crt-p it was thought that this was to do with slight movement of the lead in the header of the crt-p.The device and lead remain in service and no adverse patient effects were reported.

• Brand Name: VALITUDE X4 CRT-P
• Type of Device: IMPLANTABLE PACEMAKER WITH CARDIAC RESYNCHRONIZATION (CRT-P)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 11228036
• MDR Text Key: 228627311
• Report Number: 2124215-2021-01733
• 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: 02/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/15/2021
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 742653
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2021
• Patient Sequence Number: 1
• Patient Age: 71 YR