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

Model Number	97725
Medical Device Problem Codes	Therapy Delivered to Incorrect Body Area (1508); Malposition of Device (2616)
Health Effect - Clinical Codes	Undesired Nerve Stimulation (1980); Thrombosis (2100); Ambulation or Postural Difficulties (2544)
Date of Event	04/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: other applicable components are: product id: 977d260, serial# (b)(4), implanted: (b)(6) 2019, explanted: (b)(6) 2019 product type screening.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a manufacturer's representative and a healthcare provider (hcp) regarding a patient who trialing a wireless external neurostimulator (wens).It was reported that intra-op the patient's impedances were within the normal limit.The patient reported stimulation being in their abdomen and an x-ray confirmed the lead was in an anterior position; the physician repositioned the leads and the patient then had stimulation in their left leg and right leg.Upon discharge, the patient was unable to stand and an mri showed a blood clot occurred in their spine.An emergency surgery was performed- the lead was removed and then the blood clot was removed.The issue was resolved.No further complications reported.

• 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: 8513796
• Report Number: 3007566237-2019-00861
• Device Sequence Number: 11266353
• 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
• Report Date (Section B): 04/15/2019

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: 03/01/2020
• 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: 04/10/2019
• Initial Report FDA Received Date: 04/15/2019
• 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: 81 YR