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

Model Number 1192

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/15/2023

Event Type  Injury  

Event Description

Related manufacturer report number: 3006705815-2024-01093 it was reported that during a lead revision on 23feb2024 (related report: 3006705815-2024-01093) the patient's scs lead anchor was fragmented and a portion of the lead anchor was left in the patient.Surgery was undertaken the following day on (b)(6) 2024 but was abandoned following unsuccessful attempts to remove the fragmented anchor.Further action to address this issue is pending.

Manufacturer Narrative

Section a4: during processing of this incident, attempts were made to obtain patient weight.Further information was requested but not received.Section b3: event date is estimated.A patient experienced ineffective left side coverage due to one their leads having high impedance was reported to abbott.As a result, the lead was explanted and replaced.During the lead replacement only part of the anchor had been explanted resulting in a fragment of the lead remaining implanted within the patient.Therapy was restored.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 LEAD 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: 18842848
• MDR Text Key: 336956429
• Report Number: 1627487-2024-07374
• 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
• Report Date: 03/05/2024

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: 02/10/2023
• Device Model Number: 1192
• Device Lot Number: 7812870
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/23/2024
• Initial Date FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2021
• 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 IPG (X1); SCS LEAD (X1); SCS LEAD ANCHOR(X1)
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White