MAUDE Adverse Event Report: ABBOTT MEDICAL SWIFT-LOCK ANCHOR; Stimulator, spinal-cord, implanted (pain relief)

Model Number 1192

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

Patient Problem Implant Pain (4561)

Event Date 01/19/2024

Event Type  Injury  

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: scs swift lock anchor, model: 1192, udi:(b)(4), serial: n/a, batch: 9110830.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.

Event Description

It was reported that the patient experienced discomfort at the anchor site because the anchor was superficial due to the patient's anatomy.The patient is lean, and the anchor could not sit deep in enough in the patient's tissue to be comfortable.As a result, surgical intervention was undertaken on (b)(6) 2024 wherein the patient's anchor was explanted to address the issue.It is unknown which anchor is liable.

• Brand Name: SWIFT-LOCK ANCHOR
• Type of Device: Stimulator, spinal-cord, implanted (pain relief)
• 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: 18707651
• MDR Text Key: 335404143
• Report Number: 1627487-2024-00794
• 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
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• 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: 9110830
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2023
• 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; SCS IPG; SCS LEAD (2)
• Patient Outcome(s): Other
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 84 KG