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

Model Number 97725

Device Problems Migration or Expulsion of Device (1395); Unintended Collision (1429); Energy Output Problem (1431); Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Bruise/Contusion (1754); Electrocution (1827); Undesired Nerve Stimulation (1980); Neurological Deficit/Dysfunction (1982); Device Overstimulation of Tissue (1991); Pain (1994); Paralysis (1997); Peeling (1999); Skin Discoloration (2074); Thrombosis (2100); Tingling (2171); Dysphasia (2195); Therapeutic Response, Decreased (2271); Discomfort (2330); Hypoesthesia (2352); Malaise (2359); Joint Dislocation (2374); Impaired Healing (2378); Numbness (2415); Collapse (2416); Electric Shock (2554); Loss Of Pulse (2562)

Event Date 12/24/2017

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: neu_unknown_lead, serial# unknown, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a trial patient with an external neurostimulator (ens) via a manufacturer representative.It was reported that the patient fell during the trail and had cephalad lead migration.The patient reported that they had severe leg and foot pain after the trial.The patient also reported that they had a blood clot in their right leg that they thought was from the scs trial.The patient was sent in for imaging and the blood clot was treated afterwards.No further complications are anticipated.

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 977d260, serial# (b)(4), product type: screening device.Product id: 977d260, serial# (b)(4), product type: screening device.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

The consumer reported that she was electrocuted by the device because the lead slipped upwards.The patient had been feeling stimulation in their chest which was uncomfortable so she wanted to see if changing programs would help.The patient stated she couldn¿t move and her daughter had to grab the remote and got it turned off.The patient stated it dislocated her shoulder and went out through her right foot and all the veins in her right leg collapsed.The patient had blood clots at the top of her leg and was in the hospital (b)(6) 2017 through (b)(6) 2017 and had three surgeries to fix her leg.The patient was admitted to the hospital because they had no pulse in the right side of their whole leg and was told they would lose the leg if they didn¿t have things done.The patient noted that it was not healing where it came out of her foot and she had a big bruise on the bottom of her foot and lingering effects from this.The patient was directed to work with their healthcare professional for the symptoms she was experiencing.The patient mentioned that they had an x-ray and the leads were taken out.Additional information received from the consumer reported that she still didn¿t feel good after all that she went through.

Event Description

Additional information was received from a consumer regarding a trial patient with an external neurostimulator (ens) on (b)(6) 2018.It was reported that during the trial the patient was electrocuted and has called the manufacturer several times.The patient said the manufacturer representative (rep) took the equipment with them when it was removed.The patient mentioned they sent medical records to the manufacturer.The patient said the trial started on (b)(6) 2017 and she was electrocuted on the (b)(6).The patient said her daughter turned it off and it was removed on the (b)(6).The patient said the trial was fine from the (b)(6) to the (b)(6) when she felt stimulation in her chest.The patient tried to change the program and when she did it was like flipping a switch and she was electrocuted.The patient said when she changed the program she could not speak or let go of the remote and she could not tell her daughter what was going on.The patient's daughter turned off stim and when she did the patient collapsed and thought she dislocated her shoulder.The patient went back to the hcp for imaging for her foot and shoulder so her shoulder popped back into place.The patient said she either had an mri or an x-ray on her foot which came back okay.The patient had no pulse in her right leg after the electrocution.The patient said the hcp did imaging and found the lead slipped under the patient's neck.The lead had been in her back for low back and somehow it slipped all the way up to her neck.A rep was notified of only this lead migration information on (b)(6) 2017.The patient said she underwent an 8 hour procedure to fix it and spent christmas in the hospital.The patient said the hcp and rep said she was not electrocuted and was overstimulated.The patient said she still has pain in her leg and her leg is numb when she stands for a long time.The patient said there were no falls or other medical procedures.The rep and manufacturer were not notified of the "electrocution" complaint or the hospitalization complaint until (b)(6) 2018 and that information was submitted on time in previous regulatory report 3007566237-2018-00376.No further complications were reported.

Manufacturer Narrative

Correction: aware date: the field was aware of the lead migration on 2017-dec-22 which is the reason for this late report.All other pieces of information including the hospitalization and "electrocution" were reported on time in the past as well as now.Correction: (b)(4).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

The patient presented to her health care provider on (b)(6) 2018 for follow-up after the hospitalization for the electric injury, dislocated shoulder, and blood clots in leg.It was noted that the trial stimulator was placed on (b)(6) 2017.The lead migrated and was removed on (b)(6) 2017, at which time the patient developed significant ¿hot nail-like¿ right lower extremity pain and noticed her extremity was becoming dusky.The patient presented to the emergency room a few days later and an interventional radiology guided angiogram showed right common iliac occlusion and she was started on tissue plasminogen activator/heparin.A few days later, a right deployed bilateral common iliac artery stents (kissing stents) with extension into the aorta.She was discharged home on dual antiplatelet therapy which she has been compliant with and denies any significant residual right lower extremity pain.The patient voiced a lot of frustration with her outcome after her nerve stimulator and feels that the lead migration caused this acute occlusion.The patient continues to rely on narcotics to control her pain.The patient was looking for a new pain management specialist as she did not want to go back to who placed the trial system.The patient indicated on (b)(6) 2018 that she has intermittent paresthesia in her right foot and wants to make sure that the clot has not formed again.The patient had been compliant with dual antiplatelet therapy.The patient¿s right leg extremity is warm and well-perfused without erythema or edema and pulses easily palpable.There was a loss of fine sensation across dorsum of the foot and abundant desquamation along the patient¿s right toes which the patient states has been occurring since the shocking and is improving.There were no further complications 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
• MDR Report Key: 7247563
• MDR Text Key: 99220957
• Report Number: 3007566237-2018-00376
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00613994925961
• UDI-Public: 00613994925961
• 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
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/21/2019
• Device Model Number: 97725
• Device Catalogue Number: 97725
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 50