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

Model Number 4674

Device Problems Positioning Problem (3009); High Capture Threshold (3266)

Patient Problem Vascular Dissection (3160)

Event Date 05/08/2023

Event Type  Injury  

Event Description

It was reported that this brady lead was attempted but unsuccessful due to unknown product performance issue.Additional information was obtained, which indicates that there's a placement difficulty due to anatomy and dissection.The lead also has a high threshold and no pacing options.The device was never in service.No additional adverse patient effects were reported.

Manufacturer Narrative

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

Event Description

It was reported that this brady lead was attempted but unsuccessful due to unknown product performance issue.Additional information was obtained, which indicates that there's a placement difficulty due to anatomy and dissection.The lead also has a high threshold and no pacing options.The device was never in service.No additional adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the lead was performed.Microscopic inspections of the terminal pin assembly, lead body, and electrode tip found no anomalies.Laboratory testing was unable to reproduce the reported clinical observations and detailed analysis did not reveal any abnormalities.Analysis found no evidence of device defect, malfunction or damage outside the bounds of normal medical use.

• 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: 16947219
• MDR Text Key: 315396188
• Report Number: 2124215-2023-24600
• 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
• Report Date: 08/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4674
• Device Catalogue Number: 4674
• Device Lot Number: 895105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2023
• 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): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male