MAUDE Adverse Event Report: ABBOTT MEDICAL EPIMED RX COUDE NEEDLE; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Model Number 1314

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

Patient Problems Cerebrospinal Fluid Leakage (1772); Headache (1880)

Event Date 12/28/2023

Event Type  Injury  

Event Description

It was reported that the during a lead replacement procedure (related manufacturer reference number: 3006705815-2023-07067 ) on (b)(6) 2023, the patient experienced a csf leak when the doctor attempted to place the epidural needle.The doctor accessed a different level and completed the implant.In recovery, the patient experienced headache.Reportedly, the patient was instructed to lay flat which resolved the headache.

Manufacturer Narrative

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.

• Brand Name: EPIMED RX COUDE NEEDLE
• Type of Device: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 18539921
• MDR Text Key: 333194658
• Report Number: 1627487-2024-00325
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 05415067017864
• UDI-Public: 05415067017864
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/24/2024

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
• Device Operator: Health Professional
• Device Model Number: 1314
• Device Lot Number: 121412352
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/28/2023
• Initial Date FDA Received: 01/18/2024
• Supplement Dates Manufacturer Received: 01/23/2024
• Supplement Dates FDA Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2023
• 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
• Treatment: SCS ANCHOR; SCS IPG; SCS LEAD; SCS LEAD
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 59 KG