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

Model Number 4671

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

Patient Problems Unspecified Infection (1930); Sepsis (2067); Vascular Dissection (3160)

Event Date 09/13/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient with this lv (left ventricular) lead exhibited infection with sepsis.A system revision was performed and this lead was explanted.Upon extracting the lv lead, the vessel was ripped resulting in sternotomy or surgical intervention to repair.The patient was then treated with intravenous antibiotics.There were no adverse patient effects reported.

• 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; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 12735675
• MDR Text Key: 279536629
• Report Number: 2124215-2021-33415
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526524516
• UDI-Public: 00802526524516
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/13/2018
• Device Model Number: 4671
• Device Catalogue Number: 4671
• Device Lot Number: 518220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2016
• 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: 70 YR