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

Model Number 4674

Device Problems Failure to Capture (1081); Over-Sensing (1438); Pacing Problem (1439)

Patient Problem Malaise (2359)

Event Date 06/07/2022

Event Type  malfunction  

Event Description

It was reported that the local area representative wanted to review the loss of captured on the left ventricular (lv) lead observed during the left ventricular automatic threshold (lvat) testing.The patient was very symptomatic.Additionally, it was noted that there was oversensing with beats falling into the left ventricular protection period (lvpp) and pacing inhibition was also noted.The lv vector was reprogrammed.This lv lead remains in service, and there were no additional adverse patient effects 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: 14697867
• MDR Text Key: 294044029
• Report Number: 2124215-2022-21430
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/15/2022

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: 08/29/2022
• Device Model Number: 4674
• Device Catalogue Number: 4674
• Device Lot Number: 849485
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/07/2022
• Initial Date FDA Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2020
• 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: 48 YR
• Patient Sex: Male