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

Model Number 1116

Device Problem Failure to Advance (2524)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/27/2014

Event Type  Injury  

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.

Event Description

On (b)(6) 2014, the pt underwent a trial procedure.During procedure, the doctor was unable to advance the epidural needle due to the pt anatomy.In turn, the pt began to bleed.The procedure was extended 30-45 mins and was abandoned as a result.F/u revealed the pt is doing well.

• Brand Name: EPIDURAL NEEDLE
• Type of Device: SCS LEAD ACCESSORY
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: drew johnson ; 6901 preston rd.; plano, TX 75024 ; 9725264667
• MDR Report Key: 4117292
• MDR Text Key: 21848019
• Report Number: 1627487-2014-05680
• 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
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 08/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2014
• Device Model Number: 1116
• Device Lot Number: 3829155
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2012
• 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