MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACUITY X4 SPIRAL S; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number 4675

Device Problems Difficult to Insert (1316); Defective Device (2588)

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

Event Date 11/28/2022

Event Type  malfunction  

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 a case of an attempted implant due to the lead not allowing a stylet down it.The doctor tried multiple times to advance a stylet without success.When the lead was removed, it looked as if the lead/insulation was kinked.The lead was never in service.No adverse patient effects were reported.

Event Description

It was reported that this left ventricular (lv) lead was a case of an attempted implant due to the lead not allowing a stylet down it.The doctor tried multiple times to advance a stylet without success.When the lead was removed, it looked as if the lead/insulation was kinked.The lead was never in service.No 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.Upon receipt at our post market quality assurance laboratory, the lead was forwarded to detailed analysis for further investigation.The difficult insertion and lead kinked allegations were confirmed.Visual inspection found the entire guidewire fully in lead, stuck (unable to remove), likely due to bent or kinked guidewire near lead tip area which most likely preventing the removal of guidewire from lead.

• Brand Name: ACUITY X4 SPIRAL S
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• 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: 15985835
• MDR Text Key: 307932453
• Report Number: 2124215-2022-52838
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526524578
• UDI-Public: 00802526524578
• 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: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4675
• Device Catalogue Number: 4675
• Device Lot Number: 823813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2022
• 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 Age: 70 YR
• Patient Sex: Male