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 Purulent Discharge (1812); Unspecified Infection (1930)

Event Date 05/11/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Related manufacturing number: 3006705815-2021-02418, 3006705815-2021-02419, 3006705815-2021-02420, 1627487-2021-14079.It was reported that the patient experiencing drainage at both the ipg and lead site.As a result, the scs system was explanted and cultures were taken.The patient was placed on antibiotics.

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.Antibiotics were administered to the patient to address the issue.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.

Event Description

Additional information was received confirming the drain was pulled and the infection has cleared.

• Brand Name: SWIFT-LOCK ANCHOR
• Type of Device: SCS ANCHOR
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11902169
• MDR Text Key: 253206210
• Report Number: 1627487-2021-14080
• 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,Followup
• Report Date: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2022
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 7410378
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PERCUTANEOUS LEAD X2; SCS ANCHOR; SCS IPG; PERCUTANEOUS LEAD X2; SCS ANCHOR; SCS IPG
• Patient Outcome(s): Other