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

Model Number 4678

Device Problems Failure to Capture (1081); Positioning Problem (3009); High Capture Threshold (3266)

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

Event Date 06/10/2023

Event Type  malfunction  

Event Description

It was reported that during implant, this lead exhibited failure to capture at high outputs.The lead was repositioned, however, failure to capture was still observed.As a result, the lead was removed prior to pocket closure and another lead was implanted as replacement with acceptable measurements.No adverse patient effects were reported.The lead is expected to be returned for analysis.

Event Description

It was reported that during implant, this lead exhibited failure to capture at high outputs.The lead was repositioned, however, failure to capture was still observed.As a result, the lead was removed prior to pocket closure and another lead was implanted as replacement with acceptable measurements.No adverse patient effects were reported.Boston scientific has made three attempts to retrieve the device, however; no response was received, the device is not expected to be returned.

• Brand Name: ACUITY X4 SPIRAL L
• 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: 17172734
• MDR Text Key: 317767632
• Report Number: 2124215-2023-32140
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): Y
• Reporter Country Code: IN
• PMA/PMN Number: P010012/S398
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4678
• Device Catalogue Number: 4678
• Device Lot Number: 810327
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Male