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

Model Number	97725
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Seizures (2063)
Date of Event	10/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a manufacture representative (rep) regarding a trial patient with a wireless external neurostimulator (wens).The patient had a mild seizure when they got home after the trial implant.The rep thinks it could be the versed, fentanyl and anesthesia that is causing the seizure.The patient has a couple of catheters in their back.The healthcare professional (hcp) would have the patient turn the therapy back on (b)(6) 2018.Technical services reviewed that they are not aware of the implant causing seizures.The rep would follow up with the hcp.Additional information was received from a manufacturer representative (rep) on (b)(4) 2018.The rep indicated that the cause was unknown.Now the patient and their son are doubting that they had a seizure.No actions were taken to resolve the seizure.The patient¿s weight was unknown at the time of the event.This information was confirmed with the physician.No further complications were reported/are anticipated.
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 healthcare professional (hcp).It was reported that the patient has a history of seizures in the past and a history of brain surgery.The hcp said the patient had a spell, but they doubted it was a true seizure.No further complications were reported.

• 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: 8000928
• Report Number: 3007566237-2018-03130
• Device Sequence Number: 18939500
• 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
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/07/2019
• 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: 10/01/2018
• Supplement Date Received by Manufacturer: 11/02/2018
• Initial Report FDA Received Date: 10/24/2018
• Supplement Report FDA Received Date: 11/19/2018
• 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: Other
• Patient Age: 76 YR