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 10/10/2023

Event Type  Injury  

Manufacturer Narrative

Date of event estimated.During processing of this incident, attempts were made to obtain complete device information.Further information was requested but not received.The allegation is against 1 of 2 lead/anchor; however, it is unknown which lead/anchor(s), therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: lead, model: 3186, udi: (b)(4), serial: (b)(6), batch: a000103098.Common device name: anchor, model: 1192, udi: (b)(4), serial: n/a, batch: 7707644.

Event Description

Related manufacturer reference number: (b)(4).It was reported that the patient's lead and anchor were fractured.As a result, the patient was experiencing ineffective therapy.Surgical intervention took place where the lead and anchor where explanted and replaced to address the issue.Fracture was confirmed with fluoroscopy during surgical procedure.Therapy was restored postoperatively.Investigation was unable to determine which of the leads and anchors attributed to the event.The allegation is against 1 of 2 lead/anchor; however, it is unknown which lead/anchor(s), therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: lead, model: 3186, udi: (b)(4), serial: (b)(6), batch: a000103098.Common device name: anchor, model: 1192, udi: (b)(4), serial: n/a, batch: 7707644.

Manufacturer Narrative

The results of the investigation are inconclusive as the device was not returned for evaluation.Based on the information received, a single definitive root cause for the issue encountered was unable to 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: 18239366
• MDR Text Key: 329391500
• Report Number: 1627487-2023-05675
• 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: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/29/2022
• Device Model Number: 1192
• Device Lot Number: 7707644
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2020
• 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; SCS LEAD
• Patient Outcome(s): Other
• Patient Age: 36 YR
• Patient Weight: 61 KG