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 Post Operative Wound Infection (2446); Fluid Discharge (2686)

Event Date 10/20/2022

Event Type  Injury  

Event Description

Related manufacturer reference number: 3006705815-2022-18142.It was reported the patient experienced a post op infection at the anchor incision site.As a result, surgical intervention took place wherein the entire system was explanted to address the issue.Investigation was unable to determine which of the anchor attributed to the event.

Manufacturer Narrative

Date of event estimated.Additional components potentially involved in the event include: common device name: anchor, model: 1192, udi: (b)(4), serial: n/a, batch: 8288837.Common device name: lead, model: 3186, udi: (b)(4), serial: (b)(4), batch: a000130653.

Manufacturer Narrative

An event of infection was reported to abbott.It was conveyed that the infection originates at the anchor site(s); however, no explanted products were returned for analysis.The patient's entire system was explanted to address the issue.Investigation was unable to determine which of the anchor attributed to the event.As a result, a device history record was performed to review and confirm the sterility of the anchor(s).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: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 15820879
• MDR Text Key: 303901615
• Report Number: 1627487-2022-06251
• 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
• Report Date: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/16/2024
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 8387963
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2022
• 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.
• Patient Outcome(s): Other
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 61 KG