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

Model Number 4674

Device Problems Failure to Capture (1081); Device Dislodged or Dislocated (2923); Positioning Problem (3009); No Apparent Adverse Event (3189); High Capture Threshold (3266)

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

Event Date 11/01/2022

Event Type  malfunction  

Event Description

It was reported that this lead was unsuccessfully implanted due to an unknown product performance issue.A new lead was successfully implanted.No adverse patient effects were reported.It is unknown at this time if this lead will be returned to boston scientific for analysis.

Event Description

It was reported that this lead was unsuccessfully implanted due to an unknown product performance issue.A new lead was successfully implanted.Additional information from the field indicated this lead had no capture and/or high thresholds as a result of torturous lead placement and dislodgement.No adverse patient effects were reported.This lead was returned to boston scientific for analysis.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, visual inspection of the lead was performed.Inspection of the lead body and electrode tip found no anomalies.Laboratory testing did not identify any lead characteristics that would have resulted in the clinical observation of dislodgement.

Event Description

It was reported that this lead was unsuccessfully implanted due to an unknown product performance issue.A new lead was successfully implanted.Additional information from the field indicated this lead had no capture and/or high thresholds as a result of torturous lead placement and dislodgement.No adverse patient effects were reported.This lead was returned to boston scientific for analysis.

• 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: 15895718
• MDR Text Key: 306007990
• Report Number: 2124215-2022-50292
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526524554
• UDI-Public: 00802526524554
• 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,Followup
• Report Date: 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2022
• 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: 886144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2022
• 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): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male