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

Model Number	97725
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: product id 977d260 lot# serial# va1s40j036 implanted: explanted: product type screening device product id 977d260 lot# serial# va1s40j037 implanted: explanted: product type screening device other relevant device(s) are: product id: 977d260, serial/lot #: (b)(4), ubd: 08-jun-2022, udi#: (b)(4); product id: 977d260, serial/lot #: (b)(4), ubd: 08-jun-2022, udi#: (b)(4).(b)(4) pertain to product id: 977d260, serial# (b)(4), product type: screening device and product id: 977d260, serial# (b)(4), product type: screening device.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare professional (hcp) via a manufacturer representative regarding a patient in a clinical study with an external neurostimulator (ens).It was reported that the leads were unable to be placed during implant and were explanted.It was noted that the reason for this was unknown at the time of the report.The patient as exited from the study on (b)(6) 2018.No patient symptoms were reported.No further complications were reported/anticipated.
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.

• 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: 8015350
• Report Number: 3007566237-2018-03165
• Device Sequence Number: 1755831
• Product Code: LGW
• UDI-Device Identifier: 00613994925961
• UDI-Public: 00613994925961
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2018

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: 11/02/2019
• 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: 10/24/2018
• Supplement Date Received by Manufacturer: 10/30/2018
• Initial Report FDA Received Date: 10/29/2018
• Supplement Report FDA Received Date: 11/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR