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

Model Number	97725
Medical Device Problem Codes	Therapy Delivered to Incorrect Body Area (1508); Malposition of Device (2616)
Health Effect - Clinical Code	Undesired Nerve Stimulation (1980)
Date of Event	07/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: product id: 977c265, serial#: (b)(4), product type: lead.Other relevant device(s) are: product id: 977c265, serial/lot #: (b)(4), ubd: 03-mar-2024, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a manufacturer representative (rep) regarding a trial patient with an external neurostimulator (ens) for the treatment of complex reg pain syndrome in the left leg.The trial picture showed staggered lead placement from mid t8-t11.The specialist requested the surgeon place the lead at t9-t10.The physician did a lami lead with no xray verification in lateral position.The lead was placed at t6-t7.The patient was receiving right rib stimulation.The device was removed and the patient recovered without sequela.Additional information was received from the rep.It was reported that the lead placement and rib stimulation were noted the day of the procedure (b)(6) 2020.The cause of the issue was determined ¿ the lead was noted to be too far over to the right and placed at t7-8.The patient was also placed in the lateral position and no x-ray was done to verify where the laminectomy was at.No further patient complications were reported as a result of this event.

• 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: 10359180
• Report Number: 3007566237-2020-00352
• Device Sequence Number: 3462600
• Product Code: LGW
• UDI-Device Identifier: 00763000017590
• UDI-Public: 00763000017590
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/03/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/24/2021
• 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: 07/13/2020
• Initial Report FDA Received Date: 08/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1