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

Model Number 7424

Device Problems Intermittent Continuity (1121); Energy Output To Patient Tissue Incorrect (1209)

Patient Problems Fall (1848); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient who was implanted with an implantable neurostimulator (ins) for failed back surgery syndrome.It was reported that starting in 2013 or 2014, the patient's stimulation would go from being off to a "high mode" all by itself.This occurred when they were sleeping and when they were walking, and it would "knock the patient down".The patient got tired of getting knocked down so they met with a manufacturer representative (rep), and the rep shut the device off.Then starting a couple of years ago, the patient's sciatic pain in their hip and knee has been getting progressively worse.It was noted the patient was supposed to have a device replacement but the surgeon that was supposed to do it wasn't cleared to implant it at the clinic where it was supposed to take place.So now the patient has to wait for their insurance (medicare) to kick in to pay for the replacement surgery.It was also reported that the patient does not currently have a doctor.No further complications were reported or anticipated.

• Brand Name: ITREL II
• 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: 7470615
• MDR Text Key: 106834039
• Report Number: 3007566237-2018-01282
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/27/2018

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
• Device Operator: Health Professional
• Device Model Number: 7424
• Device Catalogue Number: 7424
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/25/2018
• Initial Date FDA Received: 04/27/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention