MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION INTRATHECAL CATHETER; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number NEU_UNKNOWN_CATH

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

Patient Problem Headache (1880)

Event Date 03/09/2022

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider via a clinical study regarding an unknown patient who was receiving an unknown drug of an unknown concentration at an unknown dose rate via an implantable pump.It was reported that the patient experienced positional headaches.The patient was scheduled to receive a blood patch but was unable to complete.The device diagnosis was indicated as not applicable, and the clinical diagnosis was spinal headache.No actions were taken to resolve the issue.The event was ongoing.The patient¿s weight was 134.8 lbs.Regarding etiology, the relationship of the event to the device or therapy was not related and was related to procedure.Additional information was received from a healthcare provider via a clinical study on (b)(6) 2022.The event had occurred during a device trial, so there was no permanent device implanted to date.

• Brand Name: INTRATHECAL CATHETER
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13937592
• MDR Text Key: 288104193
• Report Number: 2182207-2022-00526
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/29/2022

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 Model Number: NEU_UNKNOWN_CATH
• Device Catalogue Number: NEU_UNKNOWN_CATH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2022
• Initial Date FDA Received: 03/29/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 61 KG