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

Model Number 3186

Device Problems Device Operates Differently Than Expected (2913); Difficult to Advance (2920)

Patient Problems Increased Sensitivity (2065); Inadequate Pain Relief (2388)

Event Date 06/20/2014

Event Type  Injury  

Event Description

Device 2 of 3.Reference mfr report: 1627487-2014-21497.Reference mfr report: 1627487-2014-21499.It was reported the pt ((b)(6)) was receiving only unintended left leg stimulation post-operatively.X-rays confirmed the lead had migrated.Subsequently, the pt underwent surgical intervention.Pre-operative diagnostics revealed one invalid lead contact.As a result, the lead was explanted and replaced.It was also reported the physician encountered difficulty steering the new lead (device 2) to the desired location; however, after several repositioning attempts, the lead was implanted successfully.Follow-up identified the pt was receiving stimulation in the desired pain pattern; however, the amplitude was uncomfortable for the pt.Diagnostics revealed low lead impedance contacts (including ipg as device 3).There is no further info at this time.

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: palka sharma ; 6901 preston rd.; plano, TX 75024 ; 9725264823
• MDR Report Key: 3979906
• MDR Text Key: 4748084
• Report Number: 1627487-2014-21498
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/30/2014

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2016
• Device Model Number: 3186
• Device Lot Number: 4486884
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/30/2014
• Initial Date FDA Received: 07/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• 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