MAUDE Adverse Event Report: ABBOTT MEDICAL SWIFT-LOCK ANCHOR; SCS ACCESSORY

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 11/11/2020

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer reference numbers: 3006705815-2020-32857, 3006705815-2020-32858, 1627487-2020-48044.It was reported that the patient experienced an infection at the lead site.The midline incision opened up and was leaking clear fluid.The patient reported falling post-implant.As a result, the patient underwent surgical intervention on (b)(6) 2020 wherein the entire system was explanted.No additional information is available.

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.

Event Description

Additional information received stated that the patient was prescribed oral antibiotics post-explant.The infection has since resolved.

• Brand Name: SWIFT-LOCK ANCHOR
• Type of Device: SCS ACCESSORY
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 10882529
• MDR Text Key: 217646061
• Report Number: 1627487-2020-48045
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05415067024084
• UDI-Public: 05415067024084
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 01/18/2021

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: 09/01/2022
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 7627558
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/11/2020
• Initial Date FDA Received: 11/23/2020
• Supplement Dates Manufacturer Received: 01/08/2021
• Supplement Dates FDA Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PERCUTANEOUS LEAD (X2); SCS ACCESSORY; PERCUTANEOUS LEAD (X2); SCS ACCESSORY
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Weight: 100