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

Event and therapy dates are estimated.The results/method and conclusion codes along with the investigation results will be provided in the final report.

Event Description

Related manufacturer reference number: 1627487-2020-48290; related manufacturer reference number: 1627487-2020-48291; related manufacturer reference number: 1627487-2020-48292; related manufacturer reference number: 1627487-2020-48293.It was reported that patient has infection at an unknown site.Surgical intervention is expected to address the issue at a later date.

Manufacturer Narrative

Leads and anchors are no longer reportable with the new information received.

Event Description

Additional information received, indicated that patient underwent surgical intervention wherein the system was explanted and the infection was at the ipg site only.

• Brand Name: SWIFT-LOCK ANCHOR
• Type of Device: SCS ANCHOR
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 10909803
• MDR Text Key: 218506560
• Report Number: 1627487-2020-48294
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05414734400671
• UDI-Public: 05414734400671
• 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: 01/28/2017
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 4925389
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/10/2020
• Initial Date FDA Received: 11/26/2020
• 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: SCS ANCHOR; SCS IPG; SCS LEAD X 2
• Patient Outcome(s): Other
• Patient Age: 47 YR