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

Model Number K063

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

Patient Problems Abscess (1690); Unspecified Infection (1930); No Code Available (3191)

Event Date 02/07/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.(b)(4).

Event Description

It was reported that the patient with this pacemaker had an infection.Reportedly, the patient's system was removed due to abscessed lead connections related to patient condition.The patient currently has no system implanted as the patient had an ablation.Additional information from the field representative confirmed that the system extraction was due to infection.There were no complications nor adverse patient effects were reported.

• Brand Name: ADVANTIO
• 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; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 10791144
• MDR Text Key: 214742334
• Report Number: 2124215-2020-23590
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526516702
• UDI-Public: 00802526516702
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/30/2015
• Device Model Number: K063
• Device Catalogue Number: K063
• Device Lot Number: 126030
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2013
• 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: 81 YR