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

Model Number 97715

Device Problems Energy Output To Patient Tissue Incorrect (1209); Energy Output Problem (1431); Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913); Electromagnetic Compatibility Problem (2927); Insufficient Information (3190)

Patient Problems Dyspnea (1816); Undesired Nerve Stimulation (1980); Device Overstimulation of Tissue (1991); Pain (1994); Therapeutic Effects, Unexpected (2099); Burning Sensation (2146); Cramp(s) (2193); Complaint, Ill-Defined (2331); Depression (2361); Shaking/Tremors (2515); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Electric Shock (2554)

Event Date 05/01/2018

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 consumer regarding a patient who was implanted with a neurostimulator for spinal pain.It was reported that the patient was going to see her health care provider about having the current device removed because she was experiencing overstimulation.The patient stated that it was not as intense as before she had the battery changed.The patient stated that the overstimulation started occurring immediately, but then it was clarified that it started in the first part of (b)(6) of 2018.The patient noted that this is extremely difficult for her in her life and in her body and trying to maintain and make the best decision for her body.It was reported that the patient could not turn the controller on, and the manufacturer representative had told her that she could not turn it on even if she tried.This was confirmed to be in regards to the manufacturer representative thinking that the implantable neurostimulator was damaged and needed to be replaced.The patient can ¿turn it on.¿ she feels stimulation in the front of her body.She allows the battery charge inside her body to go down to 50% or lower, and she kept the battery level there in order to keep the stimulation away from her heart.She stated that she feels it in her chest and arms and it makes her shaky and jumpy.She woke up in the middle of the night because of this to where she was gasping for air and it shook her up in the bed.She noticed this issue in the first part of may.She was feeling it in the first couple of weeks in may and as the charge went down in the implantable neurostimulator battery (towards the middle of may), she checked it and could feel the stimulation going down.She then decided to leave it there and not let the implantable neurostimulator battery level go above 50%.This is the first time that she charged up her patient controller because the patient controller ran down.When she charged up the patient controller, she felt the increase in stimulation in her body.The patient did not know why the implantable neurostimulator was doing this without even having the stimulator turned on.The patient went into the pool on the day prior to the report, and when she got into the water, she felt like a toaster being thrown into a tub of water.The best way that she could describe it was that it was if her body was full of electricity.Additional information was received from a consumer regarding the patient on (b)(6) 2018.It was reported that the circumstances that led to the overstimulation with the current implant was rf ablation which is known as something that is not being said.She suspects ¿some other unauthorized modulation.¿ the patient cannot use the patient controller, and the stimulation burns.Uncontrolled stimulation is present in her entire torso.After the implant, she was told that she could not use the controller if she wanted to.This was said twice by the manufacturer representative during her healing as she complained.The patient noted that this is not true.It was working, but not on her torso.No steps have been taken by a manufacturer representative or a health care provider to resolve the overstimulation with the current implant.In order to find a sense of relief, she allowed the battery charge to decrease to 50% and remain there.She is still experiencing uncontrolled stimulation in her lower torso.The overstimulation has not at all resolved, and that this has been a difficult situation for her.There were no further complications reported.The patient¿s medical history includes taking medication for her bladder (leaking) but does not have a problem with her bladder.

Manufacturer Narrative

Concomitant medical products: product id: 97745, serial# (b)(4), product type: programmer, patient.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the patient.The patient wanted to know if they did anything else when revising the stimulator (ins, wanted to know if they did any additional work to bladder, abdomen, bowel.The patient stated they didn¿t know anything.The patient reported that she didn¿t see the doctor at her june appointment, she saw the nurse practitioner.The patient asked to see the doctor at her august appointment.The patient reported that she had radio frequency ablation and had felt continuous stimulation when stimulation was off and she went into depression.The patient had overstimulation up in the midsection.The patient mentioned allowing the battery in the controller to go down to 50%.The patient reported that stimulation in her chest and arms makes her shaky.The patient reported that she was extremely hyper sensitive and the stimulation wasn¿t on, it was only turned on after surgery.The patient reported that she felt it burning her on one part of her lower back and she turned it off.The patient reported that she was telling them about the vibration in the front and pelvic area and arms.The patient stated it was all over and extremely intense.The patient reported that she didn¿t know if they did anything else.The patient reported that there was a manufacturer¿s representative (rep) there to tell her how to operate the unit.When they turned it on it was at 0.1 and it felt like it burned her tissue.That was when she told her she turned it off.The patient reported that she had to see the doctor right after that.The patient also reported that sensations were more intense, to go outside or to go around other energies.The patient reported that going to the grocery store between the freezers, gets pain and body wants to cramp up and could hardly move her right leg which had some nerve issues she was going back to check orthopedic about.The patient reported that even when she was in her small apartment vibrations from appliances she mentioned.The patient reported that as she let the battery go down, hand was shaking, heart palpating, could see nerves jumping out of face.The patient was trying to get someone to understand this was very difficult.The patient was going down before 50% and under the controller battery then continue to let it go down and try to live with stimulation going on in body.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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7557652
• MDR Text Key: 109758771
• Report Number: 3004209178-2018-12268
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781702
• UDI-Public: 00643169781702
• 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,Followup,Followup
• Report Date: 10/05/2018

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 Expiration Date: 03/14/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/24/2018
• Initial Date FDA Received: 05/31/2018
• Supplement Dates Manufacturer Received: 07/13/2018; 08/08/2018
• Supplement Dates FDA Received: 07/17/2018; 10/05/2018
• Date Device Manufactured: 03/27/2018
• 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 Age: 61 YR