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: 1627487-2021-00302.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.

• 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: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 11177062
• MDR Text Key: 227011837
• Report Number: 1627487-2021-00303
• 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: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/15/2021

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2019
• 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: 1192, SCS ANCHOR; 3186 X 2, SCS LEAD
• Patient Outcome(s): Other