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

Model Number 4675

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 03/27/2024

Event Type  Injury  

Event Description

It was reported that during the implant procedure, when attempting to approach the left ventricle (lv) with the guidewire, a cardiac tamponade occurred due to the small and narrow lv lateral vein.The patient's blood pressure could not be measured, and the procedure was stopped.Urgent measures were required, and a catheter was inserted to drain blood.It was also noted that the patient had an infection; therefore, the physician removed the related right ventricular lead that had been previously inserted, along with the lv lead.No additional adverse patient effects were reported.This lead is not expected for return.

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

It was reported that during the implant procedure, when attempting to approach the left ventricle (lv) with the guidewire, a cardiac tamponade occurred due to the small and narrow lv lateral vein.The patient's blood pressure could not be measured, and the procedure was stopped.Urgent measures were required, and a catheter was inserted to drain blood.It was also noted that the patient had an infection; therefore, the physician removed the related right ventricular lead that had been previously inserted, along with the lv lead.No additional adverse patient effects were reported.This lead is not expected for return.This supplemental report is being submitted to include the investigation conclusion results.

• 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: 19153248
• MDR Text Key: 340720215
• Report Number: 2124215-2024-24206
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): Y
• Reporter Country Code: KS
• PMA/PMN Number: P010012/S398
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/18/2024

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: Health Professional
• Device Model Number: 4675
• Device Catalogue Number: 4675
• Device Lot Number: 825825
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/22/2024
• Supplement Dates Manufacturer Received: 04/26/2024
• Supplement Dates FDA Received: 05/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2023
• 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): Required Intervention; Hospitalization
• Patient Age: 52 YR
• Patient Sex: Female