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 Problems Unspecified Infection (1930); Post Operative Wound Infection (2446)

Event Date 10/06/2021

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.

Event Description

Related manufacturer reference number: 3006705815-2021-05323, related manufacturer reference number: 3006705815-2021-05324, related manufacturer reference number: 3006705815-2021-05325, related manufacturer reference number: 1627487-2021-17953.It was reported that the patient experienced infection.As such, surgical intervention took place on (b)(6) 2021 wherein the entire system was explanted to address the issue.The infection is being treated with iv and oral medication.

Manufacturer Narrative

A review of the lot history record identified no manufacturing nonconformities issued to the reported device that would have contributed to this event.Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.Corrected data: h6- health effect - clinical code.

Event Description

Additional information received indicates that the infection has resolved.

Manufacturer Narrative

The reported issue of infection was not confirmed.This issue cannot be confirmed with product analysis.The anchor was broken in 2 pieces as a consequence of the explant procedure.Despite the damage, tested with a lab lead and the locking mechanism functioned as intended.Production records pertinent to sterility/package were reviewed for the returned product and no non-conformances were found.The root cause of the infection could not be determined.

• Brand Name: SWIFT-LOCK ANCHOR
• Type of Device: SCS ANCHOR
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 12701018
• MDR Text Key: 278527161
• Report Number: 1627487-2021-17954
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05415067024084
• UDI-Public: 05415067024084
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092371
• 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,Followup,Followup
• Report Date: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2023
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 7864497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2021
• 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
• Treatment: SCS ANCHOR; SCS IPG; SCS LEAD X2
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 82 KG