MAUDE Adverse Event Report: ABBOTT MEDICAL SWIFT-LOCK ANCHOR

Model Number 1192

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

Patient Problem Wound Dehiscence (1154)

Event Date 12/12/2022

Event Type  Injury  

Manufacturer Narrative

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.Additional components potentially involved in the event include: common device name: swift-lock anchor, model: 1192ans, udi: (b)(4), serial: n/a, batch: 6536683.Date of event is estimated.

Event Description

It was reported that one patient anchor was sticking out of the skin.Surgical procedure was undertaken on unknown date whereby the whole system was explanted.Investigation was unable to determine which anchor was at fault.

• Brand Name: SWIFT-LOCK ANCHOR
• Type of Device: SWIFT-LOCK 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: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 16311279
• MDR Text Key: 308928837
• Report Number: 1627487-2023-00554
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05414734400671
• UDI-Public: 05414734400671
• 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
• Report Date: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2020
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 6536683
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2018
• 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
• Treatment: SCS IPG (X1); SCS LEAD (X2)
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 75 KG