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

Model Number 1192

Device Problem Fracture (1260)

Patient Problem Inadequate Pain Relief (2388)

Event Date 09/25/2020

Event Type  Injury  

Manufacturer Narrative

During processing of this complaint, attempts were made to obtain complete patient information.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.

Event Description

Related manufacturer reference number: 3006705815-2021-00118.Related manufacturer reference number: 3006705815-2021-00119.Related manufacturer reference number: 1627487-2021-00303.It was reported the patient was experiencing ineffective stimulation and stimulation was decreasing by itself.Diagnostic testing indicated high impedances.Reprogramming was initially able to address the issue; however, patient¿s both leads were found to be migrated.In turn, surgical intervention was undertaken wherein it was discovered that one of the leads was fractured at the anchor site and the anchor was also broken.The lead and anchor were explanted and replaced.The physician decided to place the new lead up higher at t4.The existing lead was also revised to t4.This addressed the issue.It is unknown which anchor was broken and was explanted, therefore both anchors are being reported.

Manufacturer Narrative

The results of the investigation are inconclusive as the returned anchor was complete and worked as design.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: SWIFT-LOCK ANCHOR
• Type of Device: SCS ANCHOR
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11177058
• MDR Text Key: 227011212
• Report Number: 1627487-2021-00302
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05415067024084
• UDI-Public: 05415067024084
• Combination Product (y/n): N
• PMA/PMN Number: K092371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2021
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 6840025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1192, SCS ANCHOR; 3186 X 2, SCS LEAD; 1192, SCS ANCHOR; 3186 X 2, SCS LEAD
• Patient Outcome(s): Other