MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	97725
Medical Device Problem Codes	Break (1069); High impedance (1291); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Codes	Pain (1994); Perforation (2001); Headache, Lumbar Puncture (2186); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: product id: neu_unknown_lead, serial#: unknown, product type: lead.Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a manufacturer representative regarding a patient who was trailing a spinal cord stimulation system.It was reported that there was a buried lead trial in progress.The neurosurgeon inserted the paddle into the epidural space and connected the extension for the purpose of the paddle trial.The surgical technician shouted that she was shocked as she was trying to seat the leads into the wireless external neurostimulator.The surgical technician was trying to use the extension screw driver to try and seat the lead into the contacts.The manufacturer representative checked impedances and the entire row of electrodes 0-7 were out with impedances greater than 40,000 ohms.The patient¿s wireless external neurostimulator was replaced post operation to see if that fixed the problem.It did not.It could be that the extensions and the leads are not seated properly or the electrical shock that the surgical technician experienced caused a shortage.The cause of why the entire row on the paddle is not functioning is unknown.The patient is currently in progress of the trial and receiving stimulation from one side of the paddle.The patient was sent home with the stimulator off until he recovered from his procedural pain such as headache.The device was currently off as of (b)(6) 2019.The patient was experiencing a lot of pain from the procedure as of (b)(6) 2019.During the surgery, the neurosurgeon noticed the dura was scarred and compressed.He dissected and created a dural tear trying to separate it from another structure.He then repaired the dura with duragen.The patient is in a lot of pain including headache.A surgery is scheduled for (b)(6) 2019 to either install a battery or explant the entire system.This decision has not been made yet by the neurosurgeon.There were no further complications reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received from a manufacturer representative (rep).It was reported that the lead would not be returned as it was discarded by the surgeon.No further complications are anticipated.

• Brand Name: INTELLIS
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 8307761
• Report Number: 3007566237-2019-00295
• Device Sequence Number: 1064467
• Product Code: LGW
• UDI-Device Identifier: 00613994925961
• UDI-Public: 00613994925961
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/20/2019
• Device Model Number: 97725
• Device Catalogue Number: 97725
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2019
• Supplement Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 03/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention