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

Model Number 4674

Device Problem No Apparent Adverse Event (3189)

Patient Problems Chest Pain (1776); Device Overstimulation of Tissue (1991); Pain (1994); Presyncope (4410)

Event Date 06/10/2022

Event Type  Injury  

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) reported what appears to be shocks while on recovery after the crt-d implant.The issue was resolved with device reprogramming.According to the patient, the issue was related to the lead.Then, the patient was at the hospital and was feeling like he was going to pass out.Vital signs looked good and the device was not checked.The patient also reported to feel chest and arm pain.There was pain some inches below the incision for the crt-d.The patient mentioned that he could see the chest vibrating, likely muscle stimulation from the left ventricular lead.The crt-d and the rest of the system remains in service.No additional adverse patient effects were reported.

Manufacturer Narrative

This investigation will be updated should further pertinent information be provided.

• 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: 15493087
• MDR Text Key: 300653025
• Report Number: 2124215-2022-38178
• 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: Consumer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/04/2024
• Device Model Number: 4674
• Device Catalogue Number: 4674
• Device Lot Number: 874945
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2022
• Initial Date FDA Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2022
• 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): Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Male