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

Model Number	97725
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product id: 977d260, serial#: (b)(4), implanted: (b)(6) 2020, explanted: (b)(6) 2020, product type: screening device.Other relevant device(s) are: product id: 977d260, serial/lot #: (b)(4), ubd: 30-oct-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 trial patient via a manufacturer representative.It was reported that the patient had one of their trialing leads removed because of rib pain.Factors that may have led to the reported issue was lead migration.The patient contacted the trialing physician  to have the leads removed the morning after they were placed.The issue was resolved at the time of the report.The lead would not be returned for analysis as the customer discarded it.The trial began on (b)(6) 2020 and the lead was removed on (b)(6) 2020.

• Brand Name: INTELLIS
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• MDR Report Key: 10978063
• Report Number: 2182207-2020-01437
• Device Sequence Number: 19898160
• Product Code: LGW
• UDI-Device Identifier: 00763000017590
• UDI-Public: 00763000017590
• Combination Product (Y/N): N
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/09/2020

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: 10/08/2021
• 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: 12/05/2020
• Initial Report FDA Received Date: 12/09/2020
• 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: Required Intervention
• Patient Age: 59 YR