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

Model Number 1192

Device Problem Fracture (1260)

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

Event Date 06/11/2021

Event Type  Injury  

Event Description

Related manufacturer report number 1627487-2021-18697.It was reported the patient was not receiving effective therapy from their system.It was found via x-ray that the lead had migrated.In turn, surgical intervention was undertaken on (b)(6) 2021 wherein the lead was repositioned.During the procedure, it was noted that the anchor was fractured, so the anchor was explanted and replaced.Postoperatively, the patient has effective therapy.

Manufacturer Narrative

Date of event is estimated.

Manufacturer Narrative

The reported event of broken anchor/general damage/material integrity problem was visually confirmed.As received, the anchor was complete and broken into two pieces.It passed functional testing.No checklist was initiated per 56-0258 as the complaint can be confirmed through visual inspection.The root cause is consistent with damage while in vivo.

• 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: 12908236
• MDR Text Key: 281507281
• Report Number: 1627487-2021-18698
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05415067024084
• UDI-Public: 05415067024084
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K092371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/28/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/07/2021
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 7394803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/17/2021
• Initial Date FDA Received: 12/01/2021
• Supplement Dates Manufacturer Received: 01/27/2022
• Supplement Dates FDA Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2019
• 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
• Patient Outcome(s): Other