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

Model Number	97725
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: product id: 977d260, serial#: (b)(4), product type: screening device.Product id: 977d260, serial/lot #: (b)(4), ubd: 15-oct-2023, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The manufacturer representative reported that the trial lead fractured and was replaced with another lead.There was no issue to the patient and the problem was resolved at the time of the report.
Additional Manufacturer Narrative
Analysis has not yet begun.A follow up report will be submitted once analysis is completed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received from a manufacturer representative (rep).The device was returned for analysis.No further complications were reported.
Additional Manufacturer Narrative
Product id neu_stylet_acc lot# serial# unknown implanted: explanted: product type accessory product id 977d260 lot# serial# (b)(4).Implanted: explanted: product type screening device h3: analysis of the lead 977d260 (sn (b)(4) ) showed the stim lead body outer insulation was cut 18.3 to 18.8 c from the distal end and the braid is exposed.Analysis of the stylet accessory showed it was bent 16.2 cm from the distal end.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: 9904522
• Report Number: 3007566237-2020-00324
• Device Sequence Number: 13625755
• Product Code: LGW
• UDI-Device Identifier: 00763000017590
• UDI-Public: 00763000017590
• 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,Followup,Followup
• Report Date (Section B): 06/25/2020

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: 06/19/2021
• 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: 03/25/2020
• Supplement Date Received by Manufacturer: 04/02/2020; 06/24/2020
• Initial Report FDA Received Date: 03/31/2020
• Supplement Report FDA Received Date: 04/15/2020; 06/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR