MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION SWIFT-LOCK ANCHOR; SCS ANCHOR

Model Number 1192

Device Problems Break (1069); Fracture (1260)

Patient Problem Inadequate Pain Relief (2388)

Event Date 05/07/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer reference number: 3006705815-2020-01840.It was reported that the patient lost stimulation due to lead migration.Lead migration was confirmed via x-rays.Additionally, x-ray revealed that the anchor was broken.As such, surgical intervention took place on (b)(6) 2020 where in the lead and anchor were explanted and replaced with new lead and anchor to address the issue.Reportedly, adequate therapy was restored post operatively.

Manufacturer Narrative

The reported event of broken anchor was visually confirmed.As received, the anchor had a break/tear at the distal end.However; the locking mechanism worked as intended.No checklist was initiated per (b)(4) as the complaint can be confirmed through visual inspection.The cause of the break is consistent with an overstress condition while in vivo.

• Brand Name: SWIFT-LOCK ANCHOR
• Type of Device: SCS ANCHOR
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer Contact: andrea deitz ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 10059702
• MDR Text Key: 191075158
• Report Number: 1627487-2020-04622
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05415067024084
• UDI-Public: 05415067024084
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K092371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/17/2020
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 6482305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2018
• 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