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

Model Number 3086

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

Patient Problems Cerebrospinal Fluid Leakage (1772); Headache (1880); Vomiting (2144)

Event Date 02/16/2015

Event Type  Injury  

Event Description

It was reported the patient experienced a wet tap during a trial procedure on (b)(6) 2015.The day after the procedure, the patient stated she experienced a headache with vomiting.The physician's assist instructed the patient to lay flat and drink plenty of caffeine for the next 24 hours.It was also reported the patient's trial procedure ended on (b)(6) 2015, which was a day early.In addition, the patient had a blood patch performed on (b)(6) 2015.The patient reported her symptoms improved following the blood patch.However, the sjm representative spoke with the patient on (b)(6) 2015 and patient reported that her headaches returned on (b)(6) 2015 and persisted for the entire day.The next day, the patient's headaches continued when bending her neck forward and backward.The physician is to contact the patient regarding the next course of action.

Manufacturer Narrative

(b)(4).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.

Event Description

Follow-up information revealed the patient continues to have headaches.The patient reported she has headaches almost daily and they are worse when she stands.The patient is to follow-up with her physician and the patient may undergo surgical intervention as the next course of action.

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 TRIAL LEAD KIT, 60CM LENGTH
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano, texas
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 4606259
• MDR Text Key: 5468212
• Report Number: 1627487-2015-23141
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/09/2015

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: 09/28/2016
• Device Model Number: 3086
• Device Lot Number: 4783378
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/19/2015
• Initial Date FDA Received: 03/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2014
• 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): Other
• Patient Age: 66 YR