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 11/20/2023

Event Type  Injury  

Event Description

It was reported that the patient experienced discomfort at the cervical anchor site.As a result, surgical intervention may be undertaken at a later date to address the issue.It is unknown which anchor is liable.

Manufacturer Narrative

Date of event is estimated.The allegation is against 1 of 2 anchors; however, it is unknown which anchor, therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: swift-lock anchor, model: 1192, udi: (b)(4), serial: n/a, batch: 7197613.

Event Description

Related manufacturer report number: 1627487-2023-06092.Additional information indicates that surgical intervention was undertaken on (b)(6) 2023 wherein the patient's anchors were moved slightly laterally away from spinous process to address the issue.

Manufacturer Narrative

The results of the investigation are inconclusive as the device was not returned for evaluation.Based on the information received, a single definitive root cause for the issue encountered was unable to be conclusively 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: 18288669
• MDR Text Key: 329993524
• Report Number: 1627487-2023-05833
• Device Sequence Number: 1
• Product Code: GZB
• 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: 02/04/2024

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: 10/02/2021
• Device Model Number: 1192
• Device Lot Number: 7197613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/20/2023
• Initial Date FDA Received: 12/07/2023
• Supplement Dates Manufacturer Received: 12/18/2023; 01/31/2024
• Supplement Dates FDA Received: 12/24/2023; 02/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2019
• 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 ANCHOR.; SCS IPG.; SCS LEAD (2).
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 91 KG