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

Model Number 4671

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 12/09/2022

Event Type  Injury  

Event Description

It was reported this left ventricular (lv) lead was explanted after 5 months of being implanted due to lead dislodged sometime after implanting.New device to match lead specification and leads were implanted.No additional adverse patient effects were reported.

Event Description

It was reported this left ventricular (lv) lead was explanted after 5 months of being implanted due to lead dislodged sometime after implanting.New device to match lead specification and leads were implanted.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, visual inspection of the lead was performed.Inspection of the lead body and tip found no anomalies.Laboratory testing did not identify any lead characteristics that would have resulted in the clinical observation of dislodgement.This is a known inherent risk of the device.

• Brand Name: ACUITY X4 STRAIGHT
• 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: 16043294
• MDR Text Key: 306088897
• Report Number: 2124215-2022-54795
• Device Sequence Number: 1
• Product Code: LWP
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 4671
• Device Catalogue Number: 4671
• Device Lot Number: 860732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2022
• 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): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female