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 Purulent Discharge (1812); Unspecified Infection (1930)

Event Date 02/21/2024

Event Type  Injury  

Manufacturer Narrative

Section b3: date of event is estimated.

Event Description

Related manufacturer report numbers: 1627487-2024-07448, 3006705815-2024-01882, 3006705815-2024-01883, 1627487-2024-07449.It was reported that patient was admitted to the hospital due to an infection of the entire scs system.There was an open, draining lumbar wound at ipg site.It was noted there acute and chronic granulation tissue with pus around the left lumbar ipg within the pocket that extended along both leads.Surgical intervention was undertaken wherein the entire system was explanted without complications and the incisions/wounds were drained and irrigated with copious amounts of antibiotic solution.

Manufacturer Narrative

A patient was admitted to the hospital due to an infection of the entire scs system was reported to abbott.There was an open, draining lumbar wound at ipg site.It was noted there acute and chronic granulation tissue with pus around the left lumbar ipg within the pocket that extended along both leads.Surgical intervention was undertaken wherein the entire system was explanted without complications and the incisions/wounds were drained and irrigated with copious amounts of antibiotic solution.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
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 18871417
• MDR Text Key: 337290561
• Report Number: 1627487-2024-07450
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/25/2021
• Device Model Number: 1192
• Device Lot Number: 7051453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2019
• 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): Other; Hospitalization
• Patient Sex: Female
• Patient Weight: 104 KG