MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE TRIAL LEAD KIT, 60CM LENGTH; SCS LEAD

Model Number 3086

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Scar Tissue (2060)

Event Date 05/11/2018

Event Type  Injury  

Manufacturer Narrative

In the event the device is returned to the manufacturer, the reported event cannot be analyzed via laboratory testing.The manufacturer 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.The manufacturer defers to the patient's physician regarding medical history.

Event Description

Device 1 of 2, reference mfr.Report#: 3006705815-2018-01304.It was reported following a trial lead procedure on (b)(6) 2018, the patient experienced pain in a different location.The original pain pattern was back.However, the patient currently has pain down his left side going from his tailbone to his groin and down the left leg to the foot.It was noted during the procedure, the physician spent 2 hours attempting to place the second trial lead due to scar tissue.The patient stated the pain was getting worse.As such, the patient underwent surgical intervention on (b)(6) 2018, wherein the leads were removed.Additional information revealed the patient's pain had not improved and the patient stated his left leg feels like it is "giving out." the patient was prescribed pain medication, which did help alleviate some of the pain.However, the patient will undergo an epidural as the next course of action.

Event Description

Device 1 of 2.Reference mfr.Report#: 3006705815-2018-01304.Follow-up information revealed the patient received an epidural injection on (b)(6) 2018, which still did not resolve the issue.However, the patient underwent a permanent implant procedure on (b)(6) 2018.

• Brand Name: OCTRODE TRIAL LEAD KIT, 60CM LENGTH
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer Contact: jennifer shepard ; 6901 preston road; plano, TX 75024 ; 9725264657
• MDR Report Key: 7582814
• MDR Text Key: 110496590
• Report Number: 3006705815-2018-01303
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2019
• Device Model Number: 3086
• Device Lot Number: A000047519
• Other Device ID Number: 05414734401555
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2017
• 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