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

Model Number MN10450-90A

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

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 11/23/2020

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

Device 3 of 3.Reference mfr.Report#: 1627487-2020-49308.Reference mfr.Report#: 1627487-2020-49309.It was reported the patient experienced a cerebral spinal fluid leak while being implanted with drg leads.As a result, the patient began to experience headaches following the procedure.In turn, the patient underwent a blood patch procedure on (b)(6) 2020.The patient was admitted to the hospital three days following the procedure due to headaches remaining present and additional symptoms of nausea, vomiting, photosensitivity, increased pain while sitting upright, and limited neck movement.Multiple tests were performed during her hospital stay.The patient was placed on an intravenous valproate regimen during her hospital to address the headaches.On (b)(6) 2020, a second blood patch procedure was performed.The patient was discharged from the hospital the following day and their symptoms resolved over time.

Event Description

Device 3 of 3 reference mfr.Report#: 1627487-2020-49308.Reference mfr.Report#: 1627487-2020-49309.

Manufacturer Narrative

Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined. .

• Brand Name: KIT IMPLANTABLE SLIM TIP LEAD, 90CM
• Type of Device: DRG LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11090991
• MDR Text Key: 224401877
• Report Number: 1627487-2020-49310
• 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: 01/27/2021

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: 01/21/2021
• Device Model Number: MN10450-90A
• Device Catalogue Number: MN10450-90A
• Device Lot Number: 6820294
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 01/06/2021
• Supplement Dates FDA Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODEL: MN10450-90A (X2)
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 51 YR
• Patient Weight: 87