MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACUITY X4 SPIRAL S; PERMANENT PACEMAKER ELECTRODES

Model Number 4675

Device Problems Pacing Problem (1439); Positioning Problem (3009)

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

Event Date 09/09/2022

Event Type  malfunction  

Event Description

It was reported that this left ventricular (lv) lead was implanted, but after placement the lead was not pacing in all the vectors.The physician tried to reposition the lead to another location but was unable to access that vessel.This lead was removed and another lead of the same model was successfully implanted in the original target vessel.No adverse patient effects were reported.The attempted lead was expected to be returned for analysis.

Manufacturer Narrative

The product is expected to be returned for analysis.This report will be updated upon return and completion of analysis.

Manufacturer Narrative

The product is expected to be returned for analysis.This report will be updated upon return and completion of analysis.Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the lead was performed.Testing was completed to assess lead electrical performance and inner/outer insulation integrity.Measurements throughout these tests were within normal limits.Microscopic inspections of the terminal pin assembly, lead body, and electrode tip found no anomalies.Laboratory testing was unable to reproduce the reported clinical observations and detailed analysis did not reveal any abnormalities.Laboratory analysis did not identify any lead characteristics that would have caused or contributed to the reported clinical observations.

Event Description

It was reported that this left ventricular (lv) lead was implanted, but after placement the lead was not pacing in all the vectors.The physician tried to reposition the lead to another location but was unable to access that vessel.This lead was removed and another lead of the same model was successfully implanted in the original target vessel.No adverse patient effects were reported.The attempted lead was expected to be returned for analysis.

• Brand Name: ACUITY X4 SPIRAL S
• Type of Device: PERMANENT PACEMAKER ELECTRODES
• 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: 15614361
• MDR Text Key: 301836212
• Report Number: 2124215-2022-41659
• 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: 01/20/2023

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: Health Professional
• Device Expiration Date: 06/29/2024
• Device Model Number: 4675
• Device Catalogue Number: 4675
• Device Lot Number: 821719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/23/2022
• Initial Date FDA Received: 10/17/2022
• Supplement Dates Manufacturer Received: 12/26/2022
• Supplement Dates FDA Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male