MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION AXIUM; SCS IPG

Model Number MN10200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 07/16/2020

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 was experiencing pain at the ipg site.As a result, the patient underwent surgical intervention during which the ipg was explanted and replaced.

Event Description

New information received indicates that the patient was feeling better post-procedure.

Manufacturer Narrative

Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.

• Brand Name: AXIUM
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10370892
• MDR Text Key: 201838753
• Report Number: 1627487-2020-23523
• Device Sequence Number: 1
• Product Code: PMP
• UDI-Device Identifier: 05415067025500
• UDI-Public: 05415067025500
• Combination Product (y/n): N
• PMA/PMN Number: P150004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 09/02/2020

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: 03/17/2019
• Device Model Number: MN10200
• Device Catalogue Number: MN10200
• Device Lot Number: DB7262
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/16/2020
• Initial Date FDA Received: 08/05/2020
• Supplement Dates Manufacturer Received: 08/27/2020
• Supplement Dates FDA Received: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 90