MAUDE Adverse Event Report: ABBOTT MEDICAL KIT TRIAL SLIM TIP LEAD, 90CM; DRG LEAD

Model Number	MN10350-90A
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	08/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A cerebrospinal fluid leak (csf) during implantation was reported to abbott.The patient underwent a drg l5 & l4 drg lead placement trial, there was a wet tap at l5, blood patch was given.Patient experienced headaches.The headaches have resolved.The results of the investigation are inconclusive as the device was not returned for evaluation.Based on the information received, a single definitive root cause for the issue encountered was unable to be conclusively determined.
Event or Problem Description
It was reported that during a drg trial on (b)(6)2024, patient experienced headache due to cerebrospinal fluid leakage.As a result, patient was given a blood patch and the headache has resolved.

• Brand Name: KIT TRIAL SLIM TIP LEAD, 90CM
• Common Device Name: DRG LEAD
• 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: 20196568
• Report Number: 1627487-2024-10930
• Device Sequence Number: 7584022
• Product Code: PMP
• UDI-Device Identifier: 05415067027146
• UDI-Public: (01)05415067027146(10)10183653(17)260206
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P150004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/11/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/06/2026
• Device Model Number: MN10350-90A
• Device Catalogue Number: MN10350-90A
• Device Lot Number: 10183653
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 86 KG