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

Model Number 4674

Device Problem Impedance Problem (2950)

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

Event Date 10/25/2022

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the system with this left ventricular (lv) lead and a cardiac resynchronization therapy defibrillator (crt-d) triggered a message stating lv lead impedance is oor in at least one vector.Impedances were within range in the currently programmed vectors.The lv lead remains in service.No adverse patient effects were reported.

• 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: 15802741
• MDR Text Key: 303750383
• Report Number: 2124215-2022-47362
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/15/2022

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: Lay User/Patient
• Device Expiration Date: 06/23/2023
• Device Model Number: 4674
• Device Catalogue Number: 4674
• Device Lot Number: 863639
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2022
• Initial Date FDA Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2021
• 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: 68 YR
• Patient Sex: Male