MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 97715

Device Problems Display or Visual Feedback Problem (1184); Energy Output Problem (1431); Pocket Stimulation (1463); Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913); Patient Device Interaction Problem (4001)

Patient Problems Dyspnea (1816); Undesired Nerve Stimulation (1980); Therapeutic Effects, Unexpected (2099); Cramp(s) (2193); Shaking/Tremors (2515); Electric Shock (2554)

Event Date 06/15/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a manufacturer representative regarding a patient with an implantable neurostimulator (ins) for the treatment of non-malignant pain.It was reported that the patient was getting shocked when using the test adaptive stimulation (test as) feature, specifically when they moved from lying back to lying right.The manufacturer representative reported that the intensities that they set up were changing values.It was determined that the intensity values were correct and that since they stopped test as while the patient was on their side, the stimulation stayed at that level.It was noted that everything seemed appropriate when the adaptive stimulation (as) was set up in the office, but when using the controller, it took a long time for the intensities to change.When the patient went home, they were feeling shocking at the battery site and they eventually had to turn the adaptive stimulation off because it was shocking them too much.The manufacturer representative tested the as with the tablet and the amplitudes were changing but were too high for the patient and they felt cramping when lying back and when they went to upright, they felt a huge cramp ¿like it exploded in the back,¿ but then the intensity came down.It was noted that the positions and intensities seemed to be changing as intended and the best course of action would be to re-do the as programming.No further complications are anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a manufacturer representative (rep) on (b)(4) 2018.It was reported that the cause of the shocking was determined to be the difference in intensities between the two positions.The rep noted that when they decreased the difference between them, the shocking got better for a while; after 24 hours, it was shocking the patient.In the end, the patient turned adaptive stim off and the shocking had stopped.The rep noted that they were planning on meeting again to troubleshoot but an appointment had not been scheduled yet.There were no further complications reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was reported that the patient was seen a couple weeks ago for adjustment in programming and as.The patient is now calling back saying she is having issues with the as.One incident the patient was in the car and the ramping up of her stimulation caused her leg to shake which caused her to press on the gas pedal unexpectedly.The patient also had to have her boyfriend run and get the controller to turn the therapy off.Troubleshooting could not be done over the phone due to lack of equipment.It was reviewed the patient should document and pay attention to the position she was in prior to the random ramping up of the stimulation to better determine how the stimulation or as parameters can be programmed to address this issue for the patient.It was also reviewed that the rep should look at transition times and transition angle once she has better feel of when and in what position this ramping is occurring.The rep did confirm that the patient has a big difference of amplitude level between the laying position and the upright position.It was also mentioned the patient texted the rep the next day stated that as is not registering the position, and is still ramping up at really odd times.In the car was the last time it happened.It went out of control.No further complications were reported.No additional patient symptoms were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from the manufacturer representative (rep).It was reported that the patient cancelled their appointment because they were not able to make it.At this time, the appointment was not rescheduled.When the rep meets with the patient, they are planning to update the transition settings and see if that helps.No further complications were reported.

Manufacturer Narrative

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 the patient has taken off adaptive stimulation.They stated when they work out, the stimulation is high and fine, just what they need.They stated when they lay down to stretch out, they get a shocking that takes their breath away and they have to lower the stimulation level.No further patient complications were reported as a result of this event.

Manufacturer Narrative

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

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Additional information was received from a manufacturer representative (rep).It was reported that the rep had the patient turn off adaptive stim because it wasn¿t working for her.Another appointment was scheduled for (b)(4) 2018.The rep was going to change transition settings to see if that helps.No further complications were reported.

Manufacturer Narrative

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

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 7637786
• MDR Text Key: 112439245
• Report Number: 3004209178-2018-14312
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781702
• UDI-Public: 00643169781702
• 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
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 34 YR