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 Implant Pain (4561)

Event Date 01/03/2024

Event Type  Injury  

Manufacturer Narrative

B3-date of event is estimated.Additional components potentially involved in the event include: common device name: lead, model: 1192, udi: (b)(4), batch: 8874960.

Event Description

Related manufacturer reference number (b)(4).Related manufacturer reference number (b)(4).Related manufacturer reference number (b)(4).It was reported that patient experienced pain at the anchor side.During a surgical intervention procedure, a fluid discharge was noticed at the ipg pocket and incision sides.As a result, the physician opted to explant the entire system to address the issue.The investigation was unable to determine the anchor that was associated with the issue.

Manufacturer Narrative

A patient experienced pain at the anchor side was reported to abbott.It was determined that during a surgical intervention procedure, a fluid discharge was noticed at the ipg pocket and incision sides.As a result, the physician opted to explant the entire system to address the issue.As a result, a device history record was performed to review and confirm the sterility of devices.Based on the documents reviewed, the source of the infection remains unknown.

• 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: 18628473
• MDR Text Key: 334369272
• Report Number: 1627487-2024-00592
• 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
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• 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: 8874960
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2023
• 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 ANCHOR
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 86 KG