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

Model Number 97714

Device Problems Device Operates Differently Than Expected (2913); Electromagnetic Compatibility Problem (2927)

Patient Problems Dyspnea (1816); Memory Loss/Impairment (1958); Tingling (2171); Complaint, Ill-Defined (2331); Numbness (2415); Confusion/ Disorientation (2553); Lethargy (2560)

Event Date 02/14/2014

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 977a260, serial# (b)(4), implanted: (b)(6) 2014, product type: lead; product id 977a260, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.(b)(4).

Event Description

It was reported that the patient could not make or received phone calls because of the stimulator.He had been through 3 phones and none of them would accept or make calls.This was intermittent.However, the patient insisted it was because of the stimulator.He left the phone on the bedside table near him and the next morning the phone did not work.He could give the phone to his wife and she could use it normally.Just when it was in his hand did it not work all the time.The patient had gotten 4 different cell phones from sprint and he had not been able to make calls on any of them.His wife could sit right next to him and her cell phones work.His wife had tried the replacement cell phone he had gotten and they worked for her.He would not touch someone else's cell phone.When he used the cell phone it constantly roamed or failed.He had tried the cell phone in different locations in his house and it sti ll did not work.The patient had turned his device off and was still having issues with the cell phone.Prior to (b)(6) 2015 he was able to make calls.The patient was also having breathing problems and insisted it was because of the stimulator.They had been to a pulmonologist and they could not find anything.Having shortness of breath was pretty constant.The patient had also been lethargic and confused and insisted the stimulator was causing this.He also had numbness and tingling in the arms and hands.The patient found an article from "mayo" clinic and reports patient may experience breathing problems, phone problems, numbness, tingling and confusion, but the patient did not have the article present.The patient did not want the manufacturing representative (rep) to look at the stimulator or troubleshoot.He wanted the system explanted and insisted that all issues would go away when it is explanted.The product issue was not resolved and the cause was not determined.It was later reported that the patient decided to keep the system.He now had a phone that worked.He wanted to keep the system as it gave pain relief.The patient later reported he still had problems of implantable neurostimulator (ins) interfering.A rep was supposed to be scheduling a test to see if his ins had been compromised in his back.More than 4 months later, the patient via a manufacturing representative (rep) reported that he had been experiencing memory loss since (b)(6) 2015 and was being treated for this issue.The patient was "feeling fuzzy" because of the stimulator.The ins was not "working right" as well.The rep had met with the patient and confirmed at that time that the stimulation was on and the patient was feeling it.The patient still thought his cell phone had not been working since the ins was implanted.When stimulation was on, he did not get service.The rep tried called the patient when stimulation was on and confirmed the patient's cell phone was working fine.Reps later reported that the patient did decide to keep the stimulator for a period of time and it worked fine for pain control.However, the patient wanted the device removed and it seemed as though the patient was going to have the system explanted in the near future.It was noted that the patient's relevant medical history includes spinal pain.

Event Description

Additional information received reported that the device was being explanted because the patient made allegations that the stimulation effected his cell phone and his memory.The rep called the patient's cell phone and it worked and stated that the device was working and that there was no malfunction.The device will be sent back for analysis and requested that the physician would received an analysis report and the device to return to the patient as the patient requested to have the implantable neurostimulator (ins) back after explant.There was a reported symptom of memory loss located in the brain.The device was explanted on friday due to the tremendous amount of damage it caused to the body over the last 12-13 months such as memory loss.The patient was meeting with a lawyer on wednesday on if he is going to sue and what he was going to do.The patient wanted to keep the explanted ins and leads.Risk management at the hospital took the device.

Manufacturer Narrative

Updated due to information received regarding additional outcome.(b)(4).

Event Description

Additional information from the consumer reported that he had a "back pain stimulated place in about 18 months".It was removed on (b)(6) 2015, and it caused "a lot" of damage to his brain.The patient "did a lot of research on fda reports on stimulation side effect to the brain".He was being treated for them now.The pain "stimulate" caused memory loss and the patient was being treated for that.A follow-up report will be sent should additional information be received.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5110860
• MDR Text Key: 27056628
• Report Number: 3004209178-2015-18896
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Followup,Followup
• Report Date: 09/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/27/2015
• Date Device Manufactured: 12/06/2013
• 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): Other; Required Intervention