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

Model Number 1192ANS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Post Operative Wound Infection (2446)

Event Date 06/13/2022

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.

Event Description

Related manufacturer number: 3006705815-2022-15083; 3006705815-2022-15198; and 3006705815-2022-15199.It was reported the patient experienced redness, drainage and irritation to the ipg and lead site due to an infection.Patient was treated with oral antibiotics.As a result, the entire scs system was explanted.

Manufacturer Narrative

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 received indicates that the patient has fully healed from the infection.

Manufacturer Narrative

Additional components potentially involved in the event include: common device name: scs anchor, model: 1192, udi: (b)(4), serial:n/a, batch: 8387968.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: ACCESSORY
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 14952695
• MDR Text Key: 295473159
• Report Number: 1627487-2022-03573
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05415067024084
• UDI-Public: 05415067024084
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/05/2023

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 Expiration Date: 03/20/2024
• Device Model Number: 1192ANS
• Device Catalogue Number: 1192
• Device Lot Number: 8387968
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/13/2022
• Initial Date FDA Received: 07/08/2022
• Supplement Dates Manufacturer Received: 08/25/2022; 01/11/2023
• Supplement Dates FDA Received: 08/31/2022; 02/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2022
• 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
• Patient Sex: Female
• Patient Weight: 122 KG