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

Model Number	97725
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: product id 3778-75 lot# serial# (b)(4).Implanted: (b)(6) 2009 explanted: product type lead.Other relevant device(s) are: product id: 3778-75, serial/lot #: (b)(4), ubd: 23-jun-2013, 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 regarding a trial patient who was using an external neurostimulator (ens) for other chronic/intract pain (trunk/limbs).It was reported that there¿was not a complaint, however, during a normal end of life replacement of his ipg, impedance testing showed all contact out of range on 0-7.¿the lead was pulled out and wiped down several times.It was moved to 8-15 header.We also testing with a wens.Every time all contacts were oor.¿they turned on the other lead and it was giving the patient good stimulation of his painful areas, so the md chose to move forward with the ipg replacement and not revise the lead.The issue was reported to be resolved at the time of the report.

• Brand Name: INTELLIS
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 12020466
• Report Number: 3007566237-2021-00061
• Device Sequence Number: 19659184
• Product Code: LGW
• UDI-Device Identifier: 00763000258115
• UDI-Public: 00763000258115
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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): 06/17/2021

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: 04/02/2022
• 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: 06/15/2021
• Initial Report FDA Received Date: 06/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1