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

Model Number	97725
Medical Device Problem Codes	High impedance (1291); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: product id: 977d260, serial#: (b)(4), product type: screening device.Other relevant device(s) are: product id: 977d260, serial/lot #: (b)(4), ubd: 28-oct-2024, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The manufacturing representative (rep) reported that there were high impedances showing in both channels during intra-op testing.They stated that there was a large amount of fluid in the epidural canal.The rep ran impedances and then switched to the opposite channel, but the issue was not resolved.The rep stated that the percutaneous trial lead was replaced with a new trial lead to resolve the issue.No symptoms 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: 10852054
• Report Number: 3007566237-2020-00388
• Device Sequence Number: 16389377
• Product Code: LGW
• UDI-Device Identifier: 00763000258115
• UDI-Public: 00763000258115
• 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): 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/09/2022
• 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: 11/13/2020
• Initial Report FDA Received Date: 11/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1