MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION AXIUM 50CM IMPLANT LEAD KIT; DRG LEAD

Model Number MN10450-50A

Device Problem Break (1069)

Patient Problem Inadequate Pain Relief (2388)

Event Date 10/25/2019

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported the patient had been receiving ineffective stimulation.X-rays confirmed the lead is broken.As a result, the patient may undergo surgical intervention to address the issue.

Manufacturer Narrative

Date of event is estimated.During processing of this complaint, attempts were made to obtain complete patient information.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# 1627487-2020-03560.Further follow-up indicates the patient had surgical intervention on (b)(6) 2020, during which the system was explanted and replaced.The issue was resolved and therapy has been restored.L1 lead has been added due to lead fracture noted.There are no allegations against the ipg.

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.

• Brand Name: AXIUM 50CM IMPLANT LEAD KIT
• Type of Device: DRG LEAD
• 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: 9323259
• MDR Text Key: 166406655
• Report Number: 1627487-2019-12794
• Device Sequence Number: 1
• Product Code: PMP
• UDI-Device Identifier: 05415067025531
• UDI-Public: 05415067025531
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2019
• Device Model Number: MN10450-50A
• Device Catalogue Number: MN10450-50A
• Device Lot Number: AB2286
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2020
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Weight: 79