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

Model Number MN10450-50A

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

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 01/19/2021

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.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 during patient's implant procedure on (b)(6) 2021.A blood patch was performed and the procedure was abandoned.Patient did not report additional symptoms post-operatively.Patient was stable and ambulatory.Later, the patient was discharged from facility.

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.

Event Description

Additional information received indicated that all reported symptoms have resolved.

• Brand Name: KIT IMPLANTABLE SLIM TIP LEAD, 50CM
• Type of Device: DRG SLIM TIP LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11272450
• MDR Text Key: 230044368
• Report Number: 1627487-2021-00808
• Device Sequence Number: 1
• Product Code: PMP
• UDI-Device Identifier: 05415067027153
• UDI-Public: 05415067027153
• 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: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2022
• Device Model Number: MN10450-50A
• Device Catalogue Number: MN10450-50A
• Device Lot Number: 7602895
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Weight: 57