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

Model Number 3186

Device Problems Kinked (1339); Device Operates Differently Than Expected (2913)

Patient Problems Scar Tissue (2060); Inadequate Pain Relief (2388); Blood Loss (2597)

Event Date 09/30/2014

Event Type  Injury  

Event Description

It was reported the patient ((b)(6)) lost stimulation.X-rays were taken and revealed a kink on the lead near the anchor site.In turn, the patient underwent surgical intervention to explant and replace the lead which resolved the issue.Additionally, it was reported the procedure was extended by approximately two hours due to scar tissue and excessive bleeding.

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
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: benjyna obasuyi ; 6901 preston rd.; plano, TX 75024 ; 9725264659
• MDR Report Key: 4212918
• MDR Text Key: 15814558
• Report Number: 1627487-2014-25658
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 09/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2015
• Device Model Number: 3186
• Device Lot Number: 4157657
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• 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: IMPLANT DATE:; SCS IPG: MODEL 3608; IMPLANT DATE:; SCS ANCHOR: MODEL 1192
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Weight: 87