MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE ULTRA; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 37712

Device Problems Break (1069); Failure to Deliver Energy (1211); Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); Paraplegia (2448)

Event Date 02/05/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3587a21, lot#: lb8145, implanted: (b)(6) 2005, product type: lead.Other relevant device(s) are: product id: 3587a21, serial/lot #: (b)(4), ubd: 10-nov-2007.If information is provided in the future, a supplemental report will be issued.

Event Description

On 2020-feb-26, information was received from a patient who was implanted with a neurostimulator.It was reported that three weeks prior to the report, the patient noticed that her stimulation was not working.The patient stated that the implantable neurostimulator (ins) was currently on and the patient programmer (pp) confirmed this, the patient did not feel the stimulation.It was noted that the pp showed that the ins was fully charged.The patient tried increasing the stimulation all the way up, but the issue didn¿t resolve.Normally, the patient had stimulation on 24/7 because of her brain stem injury.In the end, the patient was redirected to follow-up with their healthcare professional (hcp) to request a manufacturer representative (rep) to meet with the patient and to check on the ins.There were no further complications reported or anticipated.On 2020-apr-07, additional information was received from the patient reporting that the circumstances that led to the lack of stimulation was only two of the wires that led to the patient¿s brain stemwere still working.It was reported that the lead was broken near their brainstem.The manufacturer representative (rep) was able to get them turned up enough to get it so their stimulation was working the best it could until they could get in to see their neurosurgeon.It was reported that the patient had an appointment scheduled with their neurosurgeon, but due to covid19, the neurosurgeon had to put off their appointment until (b)(6).They stated that they were hoping they¿d still be able to get in on (b)(6) at 8:30 am.The patient indicated that they would need a new battery since this one was overdue/approaching end of life (b)(4).They stated that hopefully the neurosurgeon would replace the lead with a new one so it works properly.No further complications were reported/anticipated.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

Additional information was received from the patient.It was reported that two wires were working from the lead and two were not.When turned on, the patient had problems bleeding out into their arm and leg on the left side causing pain.It was stated their "hand turns into a claw, their arm bends like they've had a stroke, and their leg is almost paralyzed." the patient said a hcp wouldn't touch the device because it was too close to the brain stem and they didn't feel comfortable to try and move it after it was scarred in after 20 years.The patient was in the process of finding a surgeon to remove the battery and the wire was not going to be fixed as they were currently functioning.The patient said they went into a procedure for replacement and the hcp used electro cutting to find the pain and when they stopped the patient couldn't move their left leg, toes,or foot.The patient stayed in the facility until they were able to walk.The battery was not implanted at this time.The patient went to a different surgeon who implanted the ins in 10 minutes.

• Brand Name: RESTORE ULTRA
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 9984262
• MDR Text Key: 190565975
• Report Number: 3004209178-2020-07490
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2012
• Device Model Number: 37712
• Device Catalogue Number: 37712
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Weight: 84