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

Model Number 3086

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

Patient Problems Cerebrospinal Fluid Leakage (1772); Nausea (1970); Dizziness (2194)

Event Date 04/26/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation results will be provided in the final report.

Event Description

Device 2 of 2.Reference mfr report number: 1627487-2019-05677.It was reported that the patient experienced nausea, dizziness, and pain in the neck when sitting up post-procedure.The patient reported the issues resolved when laying flat.It was determined the patient experienced a cerebrospinal fluid (csf) leak.The patient was given fioricet and instructed to increase fluids.The patient's trial leads were subsequently pulled on (b)(6) 2019 due to these symptoms.The patient's csf leak symptoms eventually resolved.

Event Description

Reference mfr report number: 1627487-2019-05677.

• Brand Name: OCTRODE TRIAL LEAD KIT, 60CM LENGTH
• Type of Device: SCS TRIAL 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: 8612446
• MDR Text Key: 145128450
• Report Number: 1627487-2019-05678
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05414734401555
• UDI-Public: 05414734401555
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010032
• 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: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 3086
• Device Lot Number: 6880055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MODEL 3086, SCS TRIAL LEAD
• Patient Outcome(s): Other
• Patient Age: 47 YR