MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANTIO; IMPLANTABLE PACEMAKER

Model Number K064

Device Problem Battery Problem (2885)

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

Event Date 06/01/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that this implantable pacemaker was surgically explanted due to advisory, and a new device was placed.No additional adverse patient effects were reported.

• Brand Name: ADVANTIO
• Type of Device: IMPLANTABLE PACEMAKER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 19211744
• MDR Text Key: 341357720
• Report Number: 2124215-2024-26000
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526516719
• UDI-Public: 00802526516719
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N970003/S132
• 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
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/07/2016
• Device Model Number: K064
• Device Catalogue Number: K064
• Device Lot Number: 389636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2014
• 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: 75 YR
• Patient Sex: Female