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

Model Number 4674

Device Problems Device Dislodged or Dislocated (2923); Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2023

Event Type  Injury  

Event Description

It was reported that this left ventricular (lv) lead was explanted and replaced due to a non-specific product performance anomaly.No additional adverse patient effects were reported.Additional information indicated that this lv lead had dislodgement post initial implant.Physician had a lead revision and removed the lead and tried to reposition, but physician needed a longer delivery system.Also, the lead dislodgement was confirmed via fluoroscopy.Furthermore, this lead was explanted and replaced.The lead will be returned.No additional adverse patient effects were reported.

Manufacturer Narrative

This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.

Event Description

It was reported that this left ventricular (lv) lead was explanted and replaced due to a non-specific product performance anomaly.No additional adverse patient effects were reported.Additional information indicated that this lv lead had dislodgement post initial implant.Physician had a lead revision and removed the lead and tried to reposition, but physician needed a longer delivery system.Also, the lead dislodgement was confirmed via fluoroscopy.Furthermore, this lead was explanted and replaced.The lead will be returned.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the lead was performed.Detailed analysis did not confirm dislodgement allegation and difficult-to-position allegation based on visual inspection found no evidence to support lead placement difficulty.Moreover, known inherent risk was selected based on analysis evidence or field report which indicates an issue covered by the instructions for use (ifu) and therefore is deemed a known inherent risk of the device.This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.

• 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: 18466544
• MDR Text Key: 332332267
• Report Number: 2124215-2023-75528
• 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,Followup
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 4674
• Device Catalogue Number: 4674
• Device Lot Number: 900816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male