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

Model Number 1192

Device Problem Material Fragmentation (1261)

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

Event Date 12/14/2023

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.The allegation is against 1 of 2 leads; however, it is unknown which lead; therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: octrode lead kit, 60cm length, model: 3186, udi: (b)(4), serial: (b)(6), batch: a000138371.The allegation is against 1 of 2 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: swift-lock anchor, model: 1192, udi: (b)(4), serial: n/a, batch: 8207290.Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined. .

Event Description

Related manufacturer reference number:3006705815-2023-08436.Related manufacturer reference number:3006705815-2024-01200.It was reported that following significant weight loss, the patient experienced discomfort at the ipg site due to the ipg moving around in the pocket.As a result, surgical intervention was undertaken on (b)(6) 2024 wherein the ipg was repositioned, and a lead and anchor were explanted and replaced to address the issue.It was noted during the procedure that the lead had migrated out of the epidural space due to the fragmentation of the anchor.It is unknown which lead migrated or which anchor fragmented.

• 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: 18703069
• MDR Text Key: 335358996
• Report Number: 1627487-2024-00809
• Device Sequence Number: 1
• Product Code: GZB
• 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
• Report Date: 02/14/2024

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2023
• Device Model Number: 1192
• Device Lot Number: 8207290
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/02/2024
• Initial Date FDA Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2021
• 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; SCS LEAD
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 79 KG