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 11/01/2020

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.Date of explant is estimated to be (b)(6) 2020.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Reference manufacturer numbers: 3006705815-2020-32029, 3006705815-2020-32030, 3006705815-2020-32031, 1627487-2020-32602.It was reported that the patient underwent surgical intervention wherein the scs system was explanted in (b)(6) of 2019 due to an infection.The infection has since resolved and the patient has been reimplanted.Note: since it is not known which device contributed to the issue, all possible devices are being reported on.

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: 10680686
• MDR Text Key: 211428296
• Report Number: 1627487-2020-32601
• 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
• Report Date: 12/11/2020

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: 04/27/2020
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 6423757
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/25/2020
• Initial Date FDA Received: 10/14/2020
• Supplement Dates Manufacturer Received: 12/09/2020
• Supplement Dates FDA Received: 12/11/2020
• 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
• Patient Outcome(s): Other
• Patient Weight: 135