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); Impedance Problem (2950); Adverse Event Without Identified Device or Use Problem (2993); Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of medical devices: product id 977d260, serial# (b)(4), product type screening device.Product id 977d260, serial# (b)(4), product type screening device.Product id 97791, product type accessory.Product id 97791, product type accessory.Information references the main component of the system.Other relevant device(s) are: product id: 977d260, serial/lot #: (b)(4), ubd: 09-jul-2022, udi#: (b)(4) analysis of the lead ((b)(4)) found the stim lead distal end conductor was broken.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 manufacturer representative.Caller reported the screen displays an out of regulation (oor) message and settings not available on controller.Caller had patient change groups and issue still occurred oor @ 1.2 - 1.4ma.Caller indicated patient is very active.Additional information was received from the rep.Rep provided device serial numbers and patient information.The cause of oor/settings not available was not determined.Patient was reprogrammed aroundcontacts and patient was able to adjust with great pain relief.The issue was resolved and the information was confirmed with the hcp.On (b)(6) 2018, rep reported that patient completed trial today and was present for trial lead removal.Physician wants manufacturer to analyze trial leads and wens.During trial procedure on (b)(6) 2018, one electrode showed as "bad" on tablet during implant with unknown impedance values, contact number or other information about it.Caller also noted that leads were reseated on wednesday, (b)(6) 2018 and two more leads showed as "avoid" with no noted values or electrode numbers.Caller ran impedance test today which resulted in the following: electrodes 8 and 0 showed as "avoid" <(><<)>300ohms electrode 11 showed as "do not use" = all pairs with 11 over 40k ohms.Impedance value for pair 8 and 11 = >40k ohms impedance value for pair 0 and 8 = 190 ohms.No symptoms were reported and no further complications were reported/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: 7869035
• Report Number: 3007566237-2018-02728
• Device Sequence Number: 1567611
• Product Code: LGW
• UDI-Device Identifier: 00613994925961
• UDI-Public: 00613994925961
• 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): 09/12/2018

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: 11/25/2019
• Device Model Number: 97725
• Device Catalogue Number: 97725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 09/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1