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 Tingling (2171); Numbness (2415)

Event Date 12/19/2013

Event Type  Injury  

Event Description

The pt rec'd 2 trial scs leads with the same lot number.It was reported the pt developed tingling/numbness in both legs regardless of stimulation 2 days post-trial implant which did not resolve upon explant of the trial scs leads.The physician determined one of the leads was possibly pressing on a nerve and the tingling/numbness should subside; however, as of (b)(6) 2013 the issue had not resolved, worsened upon the pt's legs being propped up and was worse in the right leg.The pt was advised to consult with the physician regarding the issue if resolution did not occur.F/u identified per the pt, the issue resolved 3 days after explant and she is "doing well.".

Manufacturer Narrative

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

• Brand Name: OCTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: rachel blackwell ; 6901 preston road; plano, TX 75024 ; 9725264637
• MDR Report Key: 3581161
• MDR Text Key: 19971604
• Report Number: 1627487-2014-03034
• 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: 12/20/2013

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: 11/01/2015
• Device Model Number: 3086
• Device Lot Number: 4351176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/20/2013
• Initial Date FDA Received: 01/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• 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