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

Model Number 97725

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fainting (1847); Burning Sensation (2146); Dizziness (2194)

Event Date 12/27/2017

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: : product id neu_unknown_lead,product type lead.

Event Description

Information was received from a manufacturing representative (rep) regarding a trial patient.The rep reported that the patient had one lead implanted during their trial on (b)(6) 2017, and during the lead insertion, the patient was having lightheadedness, dizziness, and feeling warmth.It was noted that the physician gave the patient medication to prevent pain.The rep stated that the patient had called them, and left them a voicemail indicating that they had fainted at home on (b)(6) 2017.The rep called and spoke to the physician on (b)(6) 2017, and it was noted that the patient was advised to turn their stimulation off for the day.It was mentioned that the patient went to the emergency room on (b)(6) 2017, and the physician explanted the lead.The rep has not heard anything further from the patient.No further complications were reported.Indication for use is unknown.It was noted that the patient has a pre-existing history of fainting, lightheadedness, and dizziness with any type of pain, including epidural injections.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the manufacturing representative (rep) indicated that the patient¿s lead was discarded in the trash after the physician pulled them.They stated that they were not notified that the patient was going to have their leads pulled.The rep noted that the patient stated their leg pain was taken away when the stimulation was on.However, since the trial was so short, the physician does not recommend an implant and does not want to re-trial due to the patient being at high risk.The last the rep heard from the physician was that the patient was feeling a little better.No further complications were reported or anticipated.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7161720
• MDR Text Key: 96328652
• Report Number: 3007566237-2018-00051
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 97725
• Device Catalogue Number: 97725
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention