MAUDE Adverse Event Report: ABBOTT MEDICAL KIT TRIAL SLIM TIP LEAD, 50CM; DRG TRIAL SLIM TIP LEAD

Model Number MN10350-50A

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

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 10/05/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported a cerebrospinal fluid (csf) leak occurred while the physician was attempting to place the lead at l5, during a drg trial implant procedure that took place on (b)(6) 2020.As a result, the physician performed a blood patch and the patient was asymptomatic and procedure was completed.

Manufacturer Narrative

Product #1 pi main [pi-2020-0192981-01].It was reported to abbott that during a trial procedure, a cerebral spinal fluid (csf) leak occurred.The drg trial lead had been placed at l5 when the wet tap occurred.The physician performed a blood patch and the procedure was completed.The patient did not show any symptoms.All information pertaining to this event has been reviewed, issue was not product related, and no further action is required at this time.

• Brand Name: KIT TRIAL SLIM TIP LEAD, 50CM
• Type of Device: DRG TRIAL SLIM TIP LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 10776159
• MDR Text Key: 214310503
• Report Number: 1627487-2020-32884
• Device Sequence Number: 1
• Product Code: PMP
• UDI-Device Identifier: 05415067027139
• UDI-Public: 05415067027139
• Combination Product (y/n): N
• PMA/PMN Number: P150004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 12/11/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2021
• Device Model Number: MN10350-50A
• Device Catalogue Number: MN10350-50A
• Device Lot Number: 6841437
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/05/2020
• Initial Date FDA Received: 11/02/2020
• Supplement Dates Manufacturer Received: 12/10/2020
• Supplement Dates FDA Received: 12/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR