MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION; CATHETER, INFUSION

Model Number NEU_UNKNOWN_CATH

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

Patient Problems Cerebrospinal Fluid Leakage (1772); Headache, Lumbar Puncture (2186)

Event Date 09/25/2018

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 (hcp) via a clinical study on (b)(6) 2018 regarding a patient receiving dilaudid via an intrathecal (it) catheter trial.It was reported that the patient was discharged after the it pump dilaudid trial was performed.On the next day, he called the office stating he has leaking fluid with a headache.The patient was sent to the er and was admitted outpatient for a spinal fluid leak, which was confirmed via fluoroscopy.A blood patch was placed and the catheter was explanted/not replaced on (b)(6) 2018.It was stated that this was a failed it pump dilaudid trial.No product information was available.The event was resolved without sequelae on (b)(6) 2018.The etiology indicated the event was unlikely related to the device or therapy and was possibly related to the implant procedure.No further complications were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information received from a healthcare professional (hcp) via a clinical study indicated the patient's baseline weight was (b)(6).No further complications were reported.

• Type of Device: CATHETER, INFUSION
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8132810
• MDR Text Key: 129317036
• Report Number: 3007566237-2018-03510
• Device Sequence Number: 1
• Product Code: JCY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2018
• 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
• Date Manufacturer Received: 12/20/2018
• 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 Weight: 84