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

Model Number 1192

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/13/2023

Event Type  Injury  

Event Description

Related manufacturer reference number: 3006705815-2023-07813 related manufacturer reference number: 3006705815-2023-07814 it was reported the patient's one leads had migrated and the other lead was pulled out had a broken anchor as well.The issue was confirmed via x-rays.Surgical intervention was undertaken on (b)(6) 2023 during which the existing leads and anchor were explanted and replaced with a single lead.Therapy was successfully restored.

Manufacturer Narrative

Date of event is estimated.

Manufacturer Narrative

The report event of broken anchor was confirmed.As received, the returned swift lock anchor been cut in two pieces was found.The cause of the reported event is consistent with damage during use.

• 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: 18250062
• MDR Text Key: 329514222
• Report Number: 1627487-2023-05708
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2024
• Device Model Number: 1192
• Device Lot Number: 8427657
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2022
• 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.
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 82 KG