MAUDE Adverse Event Report: ST JUDE MEDICAL, NEUROMODULATION OCTRODE

Model Number 3086

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

Patient Problems Headache (1880); Tingling (2171)

Event Date 12/13/2013

Event Type  Injury  

Event Description

It was reported the patient experienced persistent headaches and a tingling sensation in the face after trial leads were implanted.Subsequently, the trial leads were removed and discarded.There was no sign of a wet tap.It was further revealed due to the history of stroke, the patient was transported to the e.R.To rule out stroke, and or cervical hematoma.Follow up revealed the ct scan was negative.The physician may refer the patient for psychological evaluation.

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
• Manufacturer (Section D): ST JUDE MEDICAL, NEUROMODULATION; plano TX
• Manufacturer Contact: melissa nkematu ; 6901 preston rd.; plano, TX 75024 ; 9723092520
• MDR Report Key: 3673845
• MDR Text Key: 4303481
• Report Number: 1627487-2014-01015
• 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: 12/13/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3086
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/13/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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