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

Model Number 1192

Device Problem Fracture (1260)

Patient Problem Inadequate Pain Relief (2388)

Event Date 09/23/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Related manufacturer reference number: 3006705815-2019-02145, 3006705815-2019-02147, 1627487-2019-08279.It was reported that one of the patient's leads had migrated after the patient experienced a fall.The issue was confirmed via x-rays.As a result, the patient underwent surgical intervention on (b)(6) 2019 wherein the entire system was explanted.During the explant procedure, it was noted a swift lock anchor was broken.It is unknown which lead and anchor are related to the issue.Therefore, all the suspected devices are being reported.

Manufacturer Narrative

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.

Event Description

Related manufacturer reference number: 3006705815-2019-02145, 3006705815-2019-02147, 1627487-2019-08279.

• Brand Name: SWIFT-LOCK ANCHOR
• Type of Device: SCS LEAD ACCESSORY
• 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: 8811785
• MDR Text Key: 151732802
• Report Number: 1627487-2019-08280
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/23/2020
• Device Model Number: 1192
• Device Lot Number: 6456335
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2018
• 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
• Treatment: MODEL: 1192, SCS LEAD ACCESSORY.; MODEL: 3186, SCS LEAD (X2).
• Patient Outcome(s): Other
• Patient Weight: 93