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

Model Number MN10450-90A

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

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 02/22/2021

Event Type  Injury  

Event Description

Related manufacturer reference number: 1627487-2021-02387.Related manufacturer reference number: 1627487-2021-02388.It was reported the patient experienced headaches following a csf leak during the implant procedure.The patient's symptoms resolved with fioricet treatment.

Manufacturer Narrative

A patient experienced headaches following a cerebrospinal fluid leak during a implant procedure was reported to abbott.The patient's symptoms resolved with fioricet treatment.The devices were not returned for evaluation or disposal.The event information pertaining to this incident has been reviewed.Based on the information received, the extent to which surgical technique contributed to the csf leak cannot be ascertained nor can the cause of the reported incident be conclusively determined.

• Brand Name: KIT IMPLANTABLE SLIM TIP LEAD, 90CM
• Type of Device: DRG SLIM TIP LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11563787
• MDR Text Key: 242067345
• Report Number: 1627487-2021-02386
• Device Sequence Number: 1
• Product Code: PMP
• UDI-Device Identifier: 05415067027160
• UDI-Public: 05415067027160
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/14/2021

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: 10/14/2022
• Device Model Number: MN10450-90A
• Device Catalogue Number: MN10450-90A
• Device Lot Number: 7697478
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/10/2021
• Initial Date FDA Received: 03/24/2021
• Supplement Dates Manufacturer Received: 05/07/2021
• Supplement Dates FDA Received: 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODEL:MN10450-90A, DRG SLIM TIP LEAD (X2); MODEL:MN10450-90A, DRG SLIM TIP LEAD (X2)
• Patient Outcome(s): Other
• Patient Age: 36 YR
• Patient Weight: 120