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

Model Number U125

Device Problems Failure to Capture (1081); Over-Sensing (1438); Off-Label Use (1494); Under-Sensing (1661)

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

Event Date 06/01/2020

Event Type  malfunction  

Manufacturer Narrative

No additional information is available at this time.This report will be updated should further information become available.

Event Description

It was reported that this device and another manufacturer's leads exhibited oversensing, low intrinsic amplitude, undersensing, and loss of capture.This patient was noted to be pacing dependent.An x-ray was performed confirming the all the leads were connected to the incorrect ports of the device.All products 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
• 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: 10277803
• MDR Text Key: 198937192
• Report Number: 2124215-2020-14107
• 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
• Report Date: 07/15/2020

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: 06/27/2021
• Device Model Number: U125
• Device Catalogue Number: U125
• Device Lot Number: 713729
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/01/2020
• Initial Date FDA Received: 07/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2019
• 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: 86 YR