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

Model Number 3186

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

Patient Problems Shock (2072); Therapeutic Effects, Unexpected (2099); Inadequate Pain Relief (2388)

Event Date 07/14/2014

Event Type  Injury  

Event Description

The pt had two model 3186 leads from the same lot.It was reported the pt was experiencing positional stimulation and shocking from his scs system.The pt did not want to meet with an sjm rep for system reprogramming.The pt's entire scs system was explanted on (b)(6) 2014.

Manufacturer Narrative

Sjm has limited info 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: logan farmer ; 6901 preston rd.; plano, TX 75024 ; 9725269611
• MDR Report Key: 4008921
• MDR Text Key: 15359416
• Report Number: 1627487-2014-08168
• 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: 07/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2015
• Device Model Number: 3186
• Device Lot Number: 4310231
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/24/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/14/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2013
• 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
• Treatment: IMLANT DATE:; SCS IPG: MODEL 3788; SCS ANCHOR: MODEL 1192 (2); IMPLANT DATE:
• Patient Outcome(s): Other
• Patient Age: 35 YR