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 10/01/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer reference# 1627487-2020-32776, 1627487-2020-32781, 1627487-2020-32777, 1627487-2020-32815, 1627487-2020-32816, 1627487-2020-32815, 1627487-2020-32817 & 1627487-2020-32778.It was reported the patient¿s entire scs system was removed due to an infection at the lead and battery site.Infection was treated with iv antibiotics.The exact explant date is unknown.

Manufacturer Narrative

An event of infection was reported to abbott.It was conveyed that the infection originates at the ipg and lead site(s).The entire system was explanted; however, no explanted products were returned for analysis.As a result, a device history record was performed to review and confirm the sterility of the ipg and lead(s).Based on the documents reviewed, the source of the infection remains unknown.Attempts were made to obtain complete event and patient information.Additional information was not provided.

• Brand Name: SWIFT-LOCK ANCHOR
• Type of Device: SCS ANCHOR
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 10713040
• MDR Text Key: 212340554
• Report Number: 1627487-2020-32818
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05414734400671
• UDI-Public: 05414734400671
• Combination Product (y/n): N
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 12/15/2020

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: 08/28/2014
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 3768689
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/01/2020
• Initial Date FDA Received: 10/21/2020
• Supplement Dates Manufacturer Received: 12/09/2020
• Supplement Dates FDA Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCS ANCHOR (3); SCS IPG; SCS LEAD (4); SCS ANCHOR (3); SCS IPG; SCS LEAD (4)
• Patient Outcome(s): Other