MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION OCTRODE LEAD KIT, 60CM LENGTH; PERCUTANEOUS LEAD

Model Number 3186

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

Patient Problem Seizures (2063)

Event Date 09/09/2020

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

Related manufacturer reference number: 1627487-2020-31901, 1627487-2020-31902.It was reported the patient was unable to adjust her therapy as the patient controller got stuck and she was unable to turn her device off.Patient was informed to use the magnet to turn the device off.Due to the stress of the situation the patient had a seizure.Surgical intervention took place wherein the system was explanted.Date of explant is unknown.

Manufacturer Narrative

During processing of this complaint, attempts were made to obtain complete patient information.

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: OCTRODE LEAD KIT, 60CM LENGTH
• Type of Device: PERCUTANEOUS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10590885
• MDR Text Key: 208742123
• Report Number: 1627487-2020-31903
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05414734401708
• UDI-Public: 05414734401708
• Combination Product (y/n): N
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2015
• Device Model Number: 3186
• Device Catalogue Number: 3186
• Device Lot Number: 4321227
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODEL 3186 LEAD; MODEL 3788 IPG
• Patient Outcome(s): Other