MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EPIDURAL NEEDLE; SCS LEAD ACCESSORY

Model Number 1114

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 01/24/2014

Event Type  Injury  

Event Description

It was reported during the implantation procedure (b)(6), the epidural needle exited the pt's skin and went beyond the sterile drape.As such, the pt had to be re-draped, and a new lead was used for implantation.The procedure was extended approx one hour due to this issue.No adverse consequences were reported as a result of the event; however, antibiotics were administered to the pt as a preventative measure.Follow-up on this matter found the pt is receiving effective therapy and the wound is healing.

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: EPIDURAL NEEDLE
• Type of Device: SCS LEAD ACCESSORY
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd.; plano TX 75024
• Manufacturer Contact: courtney weddington ; 6901 preston rd.; plano, TX 75024 ; 9725264859
• MDR Report Key: 3683377
• MDR Text Key: 15115071
• Report Number: 1627487-2014-00076
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 01/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/24/2014
• 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