MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACUITY X4 SPIRAL S; IMPLANTABLE LEAD

Model Number 4675

Device Problems Positioning Problem (3009); High Capture Threshold (3266)

Patient Problem Device Overstimulation of Tissue (1991)

Event Date 02/07/2024

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this left ventricular (lv) lead was not implanted successfully due to difficult to position.Multiple branches were attempted but the physician could not find adequate thresholds or location without phrenic.This lead was never in service, and a new lead was placed.No adverse patient effects were reported.

• Brand Name: ACUITY X4 SPIRAL S
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18806311
• MDR Text Key: 336516361
• Report Number: 2124215-2024-12128
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P010012/S398
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 4675
• Device Catalogue Number: 4675
• Device Lot Number: 827803
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2023
• 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: 79 YR
• Patient Sex: Female