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

Model Number 1192

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

Patient Problem Inadequate Pain Relief (2388)

Event Date 01/21/2023

Event Type  Injury  

Event Description

It was reported the patient is experiencing discomfort due to anchor being too close to the patient's dermis.During surgical revision on (b)(6) 2023, the doctor decided to implant the anchor further into the patient.Follow up identified the patient was doing well postoperatively.

Manufacturer Narrative

A patient experiencing discomfort at the anchor site was reported to abbott.The patient¿s anchor was revised.Therapy was restored.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.Additional components potentially involved in the event include: common device name: swift-lock anchor, model: 1192ans, udi: (b)(4), serial: n/a, batch: 7008076.

• Brand Name: SWIFT-LOCK ANCHOR
• Type of Device: SCS LEAD 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: 16314898
• MDR Text Key: 308974066
• Report Number: 1627487-2023-00536
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/05/2021
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 7008076
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/21/2023
• Initial Date FDA Received: 02/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2019
• 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 Age: 33 YR
• Patient Sex: Female
• Patient Weight: 68 KG