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

Model Number 1192

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

Patient Problem Implant Pain (4561)

Event Date 09/29/2022

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.The allegation is against [1] of [2] [components]; however, it is unknown which [component(s)], therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: anchor, model: 1192, udi: (b)(4), serial: n/a, batch: 7911872.

Event Description

Related manufacturer reference number: 3006705815-2022-17633 and 3006705815-2022-17635.It was reported the patient had discomfort at ipg, lead, and anchor site.Surgical intervention took place on (b)(6) 2022 where the system was explanted.Investigation was unable to determine which lead attributed to the event.

• 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: 15681759
• MDR Text Key: 302504398
• Report Number: 1627487-2022-05839
• 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: 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/13/2023
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 7911872
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2021
• 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 (X1); SCS LEAD (X1)
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 57 KG