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

Model Number 1192

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Inadequate Pain Relief (2388)

Event Date 11/17/2023

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.The allegation is against 1 of 2 lead 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 anchor, model: 1192, udi : (b)(4), batch/lot # 6168109.

Event Description

Related manufacturer reference number: (b)(4).It was reported patient was having ineffective stimulation and reported a fall which led to impedance issue and fracture of lead and a broken anchor.As such, surgical intervention took place where the fractured lead and broken anchor were explanted, replaced, and therapy was successfully restored.

Manufacturer Narrative

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.

• 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: 18591850
• MDR Text Key: 333896165
• Report Number: 1627487-2024-00460
• 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: 02/01/2024

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2019
• Device Model Number: 1192
• Device Lot Number: 6168109
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/10/2024
• Initial Date FDA Received: 01/26/2024
• Supplement Dates Manufacturer Received: 01/31/2024
• Supplement Dates FDA Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2017
• 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 X 1; SCS LEAD X 1
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 54 KG