MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number 97714

Device Problems Unintended Collision (1429); Device Operates Differently Than Expected (2913)

Patient Problems Undesired Nerve Stimulation (1980); Device Overstimulation of Tissue (1991); Pain (1994); Discomfort (2330); Complaint, Ill-Defined (2331); Numbness (2415); Sleep Dysfunction (2517)

Event Date 08/24/2016

Event Type  malfunction  

Event Description

Information received from a patient reported that they were experiencing issues with pain, aching, and numbness.The patient stated that they were implanted, so they could walk and the spinal cord stimulation therapy (scs) had allowed them to walk a lot further.However, it was reported that the patient¿s left arm would hurt all the time and aches, and also that their left arm was numb.The patient stated that they have been getting broken sleep due to the issue.The patient also stated that their healthcare provider (hcp) thinks the issue was being caused by a neck nerve issue.It was noted that the patient was supposed to have an mri after seeing their hcp a couple of weeks ago, but the hospital said that they wouldn¿t conduct an mri on the patient due to their implanted scs system.Mri eligibility was reviewed with the patient.The patient also mentioned taking percocet due to the incision pain from being implanted with the permanent scs system on (b)(6) 2016.The patient also reported that the stimulation sensation had been keeping the patient up at night when it was set at 3.2v.It was further reported that the patient experienced a fall on (b)(6) 2016 that could be related to this issue.The patient reported that they were walking when they fell and slammed their right shoulder into a post.After the impact, the patient rolled off the post and fell to the concrete on their left shoulder.It was noted that the patient took ibuprofen afterwards, but it didn¿t help with the pain.The patient stated that their left arm pain, aching, and numbness would occur regardless of whether stimulation was on or off.The patient stated that they turn stimulation down at night from 3.2v to 2.5v, so they can sleep.The patient was to follow up with their hcp to address the issues regarding their left arm pain, aching, numbness, sleep issues, and mri rejection by the hospital.It was noted that the patient had an appointment scheduled for (b)(6) 2016.Additional information provided on 2016-oct-05 reported that the patient inquired on how to get the device in mri mode.The patient stated that their hcp gave them a prescription for an mri of the next two weeks ago and they have been waiting a long time to get the mri.Indication for use is spinal pain.

Manufacturer Narrative

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

The consumer requested help in putting their device in mri safety mode.It was reported that the reason for the mri was because they had a fall which the patient stated was not an issue with implant because of a fall.There was a report that it wasn't turned up strong enough and fell so they had a pinched nerve and the doctor wanted to check to see what was wrong in there.Left arm, fingers, and hand were numb which also hurt while they were up walking the floor at night.The healthcare professional (hcp) sent the patient to get mris performed but none of the places would do it.An mri was performed on (b)(6) 2016 and another hcp suggested that the patient might need steroid injections after looking at the mri.The patient had terrible pain in their left hand and arm.They were taking percocet but absolutely nothing was done to resolve the issue.It was reported that the patient thinks the electrodes were pressing on their nerve and their stimulator would have to be removed but in the present, they would have to put up with the pain and lack of sleep.This was noted to be occurring for 2 months.

Manufacturer Narrative

Additional review indicated (b)(4) is no longer applicable to the event.

Event Description

Additional information received from the healthcare provider (hcp) reported that the constant pain and aching in the left arm, as well as the numbness in the left hand, were not related to the device.

Event Description

Additional information was received from a consumer.The consumer repeated information from previous calls.The patient reported that they get numbness and pain in their hands.The patient stated that their middle finger doesn't even want to bend.The patient can't feel their fingers.The patient can't pick things up otherwise they drop them.The patient stated that they have trouble sleeping.The patient has already had x-rays and cat scans done as previously reported.The patient stated that they were adjusted and had stim on for 45 minutes and it was like a lightning strike his their shoulder and went down the arm to their fingertip.Patient's finger tips were numb and had to use ice and heating pad for three days to get the hand back.The patient is scheduled to have the device removed on (b)(6) 2017.The patient is on medication at this time.

Manufacturer Narrative

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

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6012405
• MDR Text Key: 56963943
• Report Number: 3004209178-2016-21360
• Device Sequence Number: 1
• Product Code: GZB
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/27/2017
• Date Device Manufactured: 07/06/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 86 YR