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)

Patient Problem Syncope (1610)

Event Date 10/12/2020

Event Type  Injury  

Event Description

It was reported that boston scientific technical services (ts) received a call from a health care professional (hcp) about loss of capture with nine seconds of asystole and variable impedances within normal limits on the right ventricular (rv) and left ventricular (lv) leads. The patient was in the hospital because of an ablation procedure they had done the day before. The patient experienced some presyncope. It was noted that the signal artifact monitor (sam) had disabled the device's minute ventilation (mv) sensor. Ts suspected a spring contact issue, programming options were discussed and the device was reprogrammed. It was recommended to monitor the patient for twenty-four hours post programming changes. This device was included in the recent minute ventilation sensor signal oversensing advisory population, which ts discussed with the hcp. The device and leads remain in service. No additional 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
• 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: 11103883
• MDR Text Key: 224759508
• Report Number: 2124215-2020-24784
• Device Sequence Number: 1
• Product Code: NKE
• 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,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/04/2017
• Device Model Number: U125
• Device Catalogue Number: U125
• Device Lot Number: 100743
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0360-2018

Patient Treatment Data

Date Received: 01/02/2021 Patient Sequence Number: 1