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 Problem Unspecified Infection (1930)

Event Date 11/04/2020

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: 3006705815-2020-32852, 3006705815-2020-32853, 1627487-2020-48040.It was reported that the patient experienced an infection at the lead site.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

An event of infection was reported to abbott.It was conveyed that the infection originates at the lead and anchor site.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 confirmed the sterility of the leads and anchors.Based on the documents reviewed, the source of the infection remains unknown.

• Brand Name: SWIFT-LOCK ANCHOR
• Type of Device: SCS ACCESSORY
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 10892492
• MDR Text Key: 217928021
• Report Number: 1627487-2020-48041
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2020
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 6589029
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2020
• 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 Weight: 102