MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ALGOLINE; CATHETER, PERCUTANEOUS, INTRASPINAL, SHORT TERM

Model Number 81102

Device Problems Difficult to Advance (2920); Material Integrity Problem (2978)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 04/01/2018

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 via a regulatory body regarding a patient receiving unknown drug via an implanted pump.It was reported the patient was scheduled for placement of trial intrathecal catheter at cervical one.When the procedure was aborted due to difficulty encountered while attempting to pass the catheter through an arachnoid web.The catheter was withdrawn from the tuohy needle, and approximately five centimeters of the catheter was retained in the intrathecal space.The patient was to be offered other treatment options.The event of the date was sometime during the month of (b)(6) 2018.No further complications were reported.

Manufacturer Narrative

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

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) on 2018-nov-08 provided some of the patient's identifying information.The cause of the difficulty passing the catheter thru the arachnoid web was not determined.The reason for leaving 5cm the catheter in the intrathecal space was because the tip of the catheter sheared off after the case was aborted when the catheter was being withdrawn.It was noted that they felt it was safer to leave it in than to attempt to retrieve it.It was noted that the difficulty passing the catheter thru the arachnoid web had not been resolved, and no further treatment had been done.The patient's weight was (b)(6).No further complications were reported.

• Brand Name: ALGOLINE
• Type of Device: CATHETER, PERCUTANEOUS, INTRASPINAL, SHORT TERM
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 7719603
• MDR Text Key: 115011423
• Report Number: 3007566237-2018-02212
• Device Sequence Number: 1
• Product Code: MAJ
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 81102
• Device Catalogue Number: 81102
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 76