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

Model Number MN20450-50A

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

Patient Problem Edema (1820)

Event Date 10/22/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported the patient underwent a lead implant procedure.The lead was implanted successfully.Following the procedure, the patient began to experience strong back pain.Stimulation remained off while the patient's symptoms occurred.As a result, an mri was performed and a dural edema was found.In turn, the lead was removed and a dural drain was placed which addressed the patient's issue.

Manufacturer Narrative

The event information pertaining to this incident has been reviewed and no product investigation can be performed as there are no complaint allegations present nor were the circumstances of the event attributed to the implanted system.

• Brand Name: KIT IMPLANTABLE SLIM TIP LEAD, 50CM
• Type of Device: DRG LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 10791421
• MDR Text Key: 214750724
• Report Number: 1627487-2020-33325
• Device Sequence Number: 1
• Product Code: PMP
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2022
• Device Model Number: MN20450-50A
• Device Lot Number: 7582319
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other