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 Post Operative Wound Infection (2446)

Event Date 05/08/2023

Event Type  Injury  

Event Description

Related manufacturer reference number: 1627487-2023-02614, related manufacturer reference number: 1627487-2023-04530, related manufacturer reference number: 1627487-2023-04617.It was reported that the patient experienced an infection at the lead site.Antibiotic treatment did not address the issue.As such, surgical intervention took place on (b)(6) 2023 wherein a wound wash out was performed to address the issue.The infection has resolved.Patient was hospitalized and released from the hospital after a week of antibiotics.Additional information received indicates that infection did not resolve and spread to the ipg site.As such, surgical intervention took place on (b)(6) 2023 wherein the lead anchors and ipg were explanted to address the issue.The infection was being treated in hospital with iv antibiotics, post procedure of device removal.The patient has now been discharged.

Event Description

Additional information received indicates that the doctor has indicated that the infection has cleared and iv antibiotics have been stopped.

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.

• Brand Name: SWIFT-LOCK ANCHOR
• Type of Device: SCS ANCHOR
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 17830365
• MDR Text Key: 324416198
• Report Number: 1627487-2023-04616
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05415067024084
• UDI-Public: 05415067024084
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K092371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/10/2023

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 Model Number: 1192
• Device Lot Number: 8695895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/01/2023
• Initial Date FDA Received: 09/27/2023
• Supplement Dates Manufacturer Received: 09/28/2023
• Supplement Dates FDA Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization
• Patient Sex: Female