MAUDE Adverse Event Report: ABBOTT MEDICAL SWIFT-LOCK ANCHOR; SCS ANCHOR

Model Number 1192

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

Patient Problem Unspecified Infection (1930)

Event Date 10/27/2020

Event Type  Injury  

Manufacturer Narrative

The results, method, and conclusion codes along with the investigation results will be provided in final report.

Event Description

Related manufacturer reference number: 3006705815-2020-32618.Related manufacturer reference number: 3006705815-2020-32619.Related manufacturer reference number: 3006705815-2020-32620.Related manufacturer reference number: 1627487-2020-47619.It was reported the patient was admitted to the hospital with an infection.The location and cause of the infection is unknown.The infection is currently being treated via antibiotics in the hospital.

Event Description

It was reported surgical intervention was undertaken wherein the patients system was explanted due to infection.

Manufacturer Narrative

A patient had their system explanted due to infection was reported to abbott.As a result, a device history record was performed to review and confirm the sterility of devices.Based on the documents reviewed, the source of the infection remains unknown.

• Brand Name: SWIFT-LOCK ANCHOR
• Type of Device: SCS ANCHOR
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 10817864
• MDR Text Key: 215563978
• Report Number: 1627487-2020-47618
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05415067024084
• UDI-Public: 05415067024084
• Combination Product (y/n): N
• PMA/PMN Number: K092371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/12/2021

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: Health Professional
• Device Expiration Date: 06/12/2021
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 7023068
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/27/2020
• Initial Date FDA Received: 11/10/2020
• Supplement Dates Manufacturer Received: 11/04/2020; 01/08/2021
• Supplement Dates FDA Received: 11/18/2020; 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODEL: 1192, SCS ANCHOR; MODEL: 3186, SCS LEAD (X2); MODEL: 3660, SCS IPG; MODEL: 1192, SCS ANCHOR; MODEL: 3186, SCS LEAD (X2); MODEL: 3660, SCS IPG
• Patient Outcome(s): Hospitalization; Other
• Patient Weight: 59