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

Model Number 7424

Device Problems Intermittent Continuity (1121); Electromagnetic Interference (1194); Energy Output To Patient Tissue Incorrect (1209); Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

Patient Problems Stroke/CVA (1770); Muscle Weakness (1967); Device Overstimulation of Tissue (1991); Pain (1994); Burning Sensation (2146); Seizures, Grand-Mal (2168); Twitching (2172); Discomfort (2330); Loss of consciousness (2418); Cognitive Changes (2551); Electric Shock (2554)

Event Type  Injury  

Event Description

Information was received from a health care professional (hcp) regarding a patient who was implanted with a neurostimulator. It was reported that there was electromagnetic interference (emi) with security gates and other magnets which caused shocking. It was stated that the ins is shocking at full settings. It was reported the patient uses a magnet to turn off the implantable neurostimulator (ins) when this happens. The caller was a general surgeon and wanted to discuss explant of the ins only. It was unknown when the emi with shocking started. It was believed that the patient did not have a current managing physician. It was reviewed that there were multiple options including explant or having the ins checked and reprogrammed. No further complications were reported.

Manufacturer Narrative

(b)(4). A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was reported by the consumer on 2017-04-28 that the patient began having a lot of problems and noted that the device became ¿spasmatic¿ as almost anything would turn it on electronically. It was reported that the stimulator could be turned on by the patient being near multiple electrical sources including a satellite, microwave, cordless drill, amplifier, and church sound equipment. It was reported that it happened with just about anything with an electric field when the patient could ¿get in line with it. ¿ this was reported to be frustrating for the patient as the stimulator would ¿come on at its highest range. ¿ it was stated that the stimulator had 3 ranges and the patient knew it came on at the highest range. It was reported that the electrodes were implanted in the epidural area between the patient¿s shoulder blades at the ¿l7 area. ¿ this information is most likely indicating that the patient¿s lead was implanted in the thoracic area. It was reported that when stimulation turned on it stung, burned, made the patient¿s eyes flutter, and the patient could not concentrate. The patient had a wood shop for their hobby and that was ¿when everything went bananas¿ as the patient used an electrical saw and drill there. It was reported that the occurrence elevates their blood pressure. The patient had seen doctors about it but it was reported that no one wanted ¿to fool with it. ¿ it was reported that the patient lost consciousness and the doctors thought they ¿perhaps had a stroke. ¿ it was reported that the patient had ¿grand ma[l] seizures,¿ was hospitalized, treated, and then went to rehab about 5 years ago. It was reported that the patient had always had diabetes and high blood pressure. It was reported that a couple of weeks ago the same thing happened with the patient having a ¿seizure of some sort¿ except they also had weakness in their left arm grip and pain. It was reported that the doctors could not find a cause as they could not conduct an mri due to the stimulator. Scans and x-rays were performed and determined that the implanted device must be creating the problem. Per the consumer, the health care professional (hcp) told the patient to call the manufacturer so that the device could be reprogrammed. The current device was implanted in 1994 and was the patient¿s second device. It was noted that the patient had a scheduled hcp appointment for tuesday ((b)(6) 2017). It was reported that the patient was implanted with scs because they had 4 back surgeries prior to being implanted. No further complications were reported.

Manufacturer Narrative

Other applicable components are: product id 3586 lot# serial# (b)(4) implanted: (b)(6) 1990 explanted: product type lead. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare provider (hcp) who reported that the patient had only been seen once, which was on the day of the report. It was reported that basic x-rays were done, but they did not know the results of the x-rays. It was reported that the patient was not seen before or after that because the physician could not perform the surgery on the patient with a "tens unit (stimulator)". It was reported that the patient's primary healthcare physician had referred the patient back to a neurosurgeon. The patient's weight was reported. The hcp had no further information on who the primary physician or neurosurgeon were. No further complications were reported/anticipated.

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 3586, serial (b)(4), implanted: (b)(6) 1990, product type: lead. If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the patient. It was reported that over the years, all tests and hospitalization never showed that the ins was causing the patient¿s adverse events of stroke, loss of consciousness, seizure, eye fluttering, grip weakness, pain and decreased ability to concentrate. All tests, x-rays, scans, etc. , were negative. The implant and lead were removed (b)(6) 2017. All symptoms ceased. The emi/shocking was resolved. It was unknown what had become of the device. No further complications were reported/anticipated.

Manufacturer Narrative

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

• 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: 6530296
• MDR Text Key: 74052301
• Report Number: 3007566237-2017-01641
• 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,health professional

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 7424
• Device Catalogue Number: 7424
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/03/2017
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/28/2017 Patient Sequence Number: 1