MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INGENIO; PACEMAKER

Model Number K173

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

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930); Staphylococcus Aureus (2058); Sepsis (2067)

Event Date 10/13/2020

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 pacemaker had infection.Reportedly, the patient had staphylococcus aureus infection and planning for a system explant.There were no additional adverse patient effects reported.All available information indicates that the pacemaker remains in service.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, additional information from product investigation indicates that the allegation against the device was not confirmed.The device was analyzed, passed all the baseline tests and exhibited normal device functions.This supplemental report is being filed to correct the b5: describe event or problem; d5: operator of device; d9: device avail for eval; d9: device return date; g2: report source; h2: follow-up type; h3: device eval by manufacturer; h6: patient codes; and h7: if remedial act init, type.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient with this pacemaker had infection.Reportedly, the patient had staphylococcus aureus infection and planning for a system explant.There were no additional adverse patient effects reported.All available information indicates that the pacemaker remains in service.Additional information indicated that this pacemaker was part of system revision due to staphylococcus aureus infection and sepsis.No additional adverse patient effects were reported.The pacemaker was explanted.

• Brand Name: INGENIO
• Type of Device: 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: 11182185
• MDR Text Key: 227487005
• Report Number: 2124215-2020-28198
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526516825
• UDI-Public: 00802526516825
• 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: Other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/21/2024

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/18/2015
• Device Model Number: K173
• Device Catalogue Number: K173
• Device Lot Number: 147013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 01/15/2021
• Supplement Dates Manufacturer Received: 05/14/2024
• Supplement Dates FDA Received: 05/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2013
• 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: 82 YR
• Patient Sex: Male