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

Model Number U128

Device Problem High impedance (1291)

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

Event Date 06/23/2020

Event Type  malfunction  

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited intermittent fluctuations in impedance measurements with no conclusive evidence of a product malfunction; please refer to the description for more information regarding the specific circumstances of this event.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) system exhibited high out of range pacing impedances on the left ventricular (lv) lead, measuring 2030 ohms after being implanted for almost a month.A lead safety switch (lss) was also declared which switched the pace/sense configuration from bipolar to unipolar.Technical services discussed programming options.The health care professional will discuss with the physician to decide when the patient should come in for a follow-up.It was also noted that a signal artifact monitoring (sam) episode occurred due to high out of range pacing impedances as there is no right atrial (ra) lead.At this time, this crt-d and lv lead remains in service.No 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
• 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: 10617929
• MDR Text Key: 209626293
• Report Number: 2124215-2020-19656
• 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
• Report Date: 10/01/2020

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: 05/07/2022
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 752321
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2020
• Initial Date FDA Received: 10/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2020
• 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: 83 YR