MAUDE Adverse Event Report: ABBOTT MEDICAL KIT IMPLANTABLE SLIM TIP LEAD, 90CM; DORSAL ROOT GANGLION STIMULATOR FOR PAIN RELIEF

Model Number MN10450-90A

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

Patient Problems Fever (1858); Headache (1880); Meningitis (2389); Post Operative Wound Infection (2446)

Event Date 11/29/2023

Event Type  Injury  

Event Description

It was reported that the patient began exhibiting symptoms of a suspected meningitis infection: fever and headache.The patient was admitted to the hospital on 29nov2023 and intravenous antibiotics were administered to address the issue.Investigation was unable to determine which of the leads attributed to the event.

Manufacturer Narrative

Date of event is estimated.Additional components potentially involved in the event include: common device name: drg lead, model: mn10450-90a, udi: (b)(4), serial: n/a, batch: ab2425.

Event Description

It was reported that the infection resolved and the patient was released from the hospital.

• Brand Name: KIT IMPLANTABLE SLIM TIP LEAD, 90CM
• Type of Device: DORSAL ROOT GANGLION STIMULATOR FOR PAIN RELIEF
• 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: 18395814
• MDR Text Key: 331358129
• Report Number: 1627487-2023-05985
• Device Sequence Number: 1
• Product Code: PMP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150004
• 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: 01/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/20/2019
• Device Model Number: MN10450-90A
• Device Lot Number: AB2425
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2017
• 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: DRG IPG (X1).; DRG LEAD (X1).
• Patient Outcome(s): Other
• Patient Weight: 82 KG