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

Model Number 3086

Device Problems Therapy Delivered to Incorrect Body Area (1508); Failure to Advance (2524); Device Operates Differently Than Expected (2913)

Patient Problems Scar Tissue (2060); Therapeutic Effects, Unexpected (2099); Inadequate Pain Relief (2388)

Event Date 04/21/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, the pt underwent a trial procedure.During the procedure, the doctor experienced difficulty placing the lead due to scar tissue.In turn, the pt experienced stimulation in unintended areas.The procedure was abandoned after 3 hrs.

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
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: ahmad johnson ; 6901 preston rd.; plano, TX 75024 ; 9725264667
• MDR Report Key: 3820932
• MDR Text Key: 4497956
• Report Number: 1627487-2014-05335
• 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: 04/21/2014

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: 09/01/2015
• Device Model Number: 3086
• Device Lot Number: 4261173
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/29/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/21/2014
• Initial Date FDA Received: 05/12/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2013
• 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