MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EPIDURAL NEEDLE, 14 GAUGE, 6 (15CM); SCS EPIDURAL NEEDLE

Model Number 1116

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/15/2018

Event Type  Injury  

Manufacturer Narrative

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

It was reported the physician was unable to access epidural space due to patient having a fusion all the way up to vertebral level t10 through the epidural needle.As a result, the trial was abandoned.The device information is unknown at this time.The initial reporter is unknown at this time.

• Brand Name: EPIDURAL NEEDLE, 14 GAUGE, 6 (15CM)
• Type of Device: SCS EPIDURAL NEEDLE
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer Contact: seema wakdikar ; 9725268205
• MDR Report Key: 7672548
• MDR Text Key: 113498092
• Report Number: 1627487-2018-06037
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/03/2020
• Device Model Number: 1116
• Device Catalogue Number: 1116
• Device Lot Number: 6366402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 66 YR