MAUDE Adverse Event Report: ST. JUDE MEDICAL-NEUROMODULATION OCTRODE; SCS LEAD

Model Number 3086

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

Patient Problems Cerebrospinal Fluid Leakage (1772); Headache (1880); Nausea (1970)

Event Date 05/28/2014

Event Type  Injury  

Event Description

Device 1 of 2: reference mfr report: 1627487-2014-02444.It was reported a csf leak occurred during the patient;s scs trial.The procedure was successfully completed with no issues other than normal procedure discomfort.The patient did not have a headache or nausea following the procedure until later that evening.On (b)(6) 2014 the patient was treated for nausea and significant pain on her left side.The physician examined the patient's surgical site and when he pressed on the area around the leads csf was observed coming out from the surgical site.The patient's leads were removed, and the pain on her left side subsided.Follow up on (b)(4) 2014 identified the physician reported the patient's headache came back and a blood patch would be performed.

Manufacturer Narrative

Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.

• Brand Name: OCTRODE
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL-NEUROMODULATION; plano TX
• Manufacturer Contact: arnie ochoa ; 6901 preston rd.; plano, TX 75024 ; 9723098090
• MDR Report Key: 3950297
• MDR Text Key: 19800646
• Report Number: 1627487-2014-02443
• Device Sequence Number: 1
• Product Code: GZB
• 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
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2016
• Device Model Number: 3086
• Device Lot Number: 4573032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• 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): Required Intervention
• Patient Age: 46 YR