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 Codes	Pain (1994); Sepsis (2067)
Date of Event	12/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: product id: 97715, serial#: (b)(4), implanted: (b)(6) 2017, product type: implantable neurostimulator.Product id: 977c165, serial#: (b)(4), implanted: (b)(6) 2017, product type: lead.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare professional via manufacturer representative, regarding a trial patient who was using an external neurostimulator (ens) for spinal pain.It was reported that the patient had a trial on (b)(6) and had the leads removed on (b)(6).Patient went home and complained of back pain.Doctor went over reasons to call back or be seen and advised if pain gets worse then go to er.There were no external factors that may have led to or contributed to the issue.No troubleshooting was done.Patient's weight was asked but unknown.Hcp had no further information.No further complications were reported.Additional information was received from the rep.It was reported that the patient had a trial performed with the permanent implant in place.The lead and the wens serial number was provided.The patients back pain was resolved by patient going to the er and then sent to icu. the back pain was not resolved.Device removal is still unknown.The provided information was confirmed with the hcp.No further complications were reported.Additional information was received from a healthcare provider via a manufacturer representative regarding a patient who was implanted with a neurostimulator (ins) for spinal pain.It was reported that the patient was at the hospital and in icu for days, being treated and was septic.The healthcare provider removed the implanted neurostimulator which resolved the issue.Patient didn't report symptoms of infection.No other symptoms were reported.No further complications were reported or 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: 9586955
• Report Number: 3007566237-2020-00077
• Device Sequence Number: 2697076
• Product Code: LGW
• UDI-Device Identifier: 00763000017590
• UDI-Public: 00763000017590
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/14/2020

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: 10/11/2020
• 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: 12/03/2019
• Initial Report FDA Received Date: 01/14/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 55 YR