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

Model Number	1116
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cerebrospinal Fluid Leakage (1772); Headache (1880)
Date of Event	07/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During processing of this complaint, attempts were made to obtain complete patient information.Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
Event or Problem Description
It was reported that during a perm implant procedure on (b)(6) 2020, the physician punctured the epidural space during entry resulting in a cerebrospinal fluid (csf) leak.The physician completed the procedure by entering at a different level.Post-operatively, the patient experienced a headache which resolved over time with prescribed medication.

• Brand Name: EPIDURAL NEEDLE, 14 GAUGE, 6' (15CM)
• Common Device Name: ACCESSORY
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10389189
• Report Number: 1627487-2020-23856
• Device Sequence Number: 16847450
• Product Code: LGW
• UDI-Device Identifier: 05414734400145
• UDI-Public: 05414734400145
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/21/2021
• Device Model Number: 1116
• Device Catalogue Number: 1116
• Device Lot Number: 7224977
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 08/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 41 YR