MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION OCTRODE LEAD KIT, 30CM LENGTH; SCS LEAD

Model Number	3183
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burning Sensation (2146)
Date of Event	05/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.Date of event is estimated.
Event or Problem Description
It was reported that the patient experienced burning sensation at the electrode site with stimulation on and while standing.The reported symptom disappears once the stimulation is turned off.Impedance check and x-rays showed no anomaly.Reprogramming was unable to resolve the issue.As such, surgical intervention may take place at a later date to address the issue.
Event or Problem Description
Follow up information received identified the patient's scs lead was successfully replaced, the burning along the electrode no longer exists.
Additional Manufacturer Narrative
The results of the investigation are inconclusive, and the root cause of the reported incident is unknown as the device was not returned for analysis.

• Brand Name: OCTRODE LEAD KIT, 30CM LENGTH
• Common Device Name: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10603449
• Report Number: 1627487-2020-31908
• Device Sequence Number: 3054805
• Product Code: LGW
• UDI-Device Identifier: 05415067017420
• UDI-Public: 05415067017420
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/24/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/12/2019
• Device Model Number: 3183
• Device Catalogue Number: 3183
• Device Lot Number: 6152465
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/15/2020
• Supplement Date Received by Manufacturer: 10/21/2020; 11/17/2020
• Initial Report FDA Received Date: 09/29/2020
• Supplement Report FDA Received Date: 11/09/2020; 11/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other