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

Model Number 97714

Device Problems Electromagnetic Interference (1194); Failure to Deliver Energy (1211); Device Operates Differently Than Expected (2913); Electromagnetic Compatibility Problem (2927)

Patient Problems Chest Pain (1776); Headache (1880); Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Date 07/24/2016

Event Type  malfunction  

Event Description

Information was received from a regarding a patient who was implanted with a neurostimulator for spinal pain.It was reported that the patient turned their device off when they went to the emergency room for chest pain and had an ekg because the implantable neurostimulator (ins) had been messing with the machine.The patient turned it on again about 9 hours later but it seemed like they were not getting the same kind of stimulation that they used to get.The patient stated that it was still working but that it just was not acting the same.The patient stated that there used to be a little on the left and more on the right.Every 15 minutes they would get a little stronger pulse out of it.The patient could still feel it but just not like they used to.This had all occurred 2 weeks ago on sunday.In the er, the patient had an x-ray, an ekg, and some bloodwork.There was a request for an appointment with a manufacturer representative.

Event Description

Additional information received from the consumer indicated that they had an appointment on (b)(6) 2016.New neck x-rays were ordered and done on (b)(6) 2016.They were supposed to hear from someone from the manufacturer to reset the machine.They were still waiting to hear and had all of the x-rays for comparison.The issue was not resolved.The patient was leaving for vacation on (b)(6) 2016 and would really like to have this fixed so they could enjoy their vacation.

Event Description

Additional information received from the consumer reported in 2016 they went into the hospital because they were having chest pains so they turned the unit off because it was messing up the ekg machine.When the consumer tried to get it to come back up again it wouldn't work, and they hadn't messed with it since.It was noted the consumer had the device for headaches and shooting pain up the back of the neck and an inch and a half from the ear on the right side.According to the consumer they ¿got up to a point and made a 90 degree turn and comes forward and it took a while to go away¿ so they took oxycodone and a muscle relaxer to get it to go away.During the call the patient programmer (pp) was used to connect with the device which showed stimulation was on and set on program b at.50 volts.According to the consumer they used to be able to feel it when it came on and would get this ¿little kind of fuzzy feeling¿ which is how they knew it was working, but they didn't get that anymore and couldn't tell if it was doing anything for their headaches as they had no feeling if of it working at all.It was noted the consumer had x-rays done previously but didn't know if the lead was in place or not.The rep.Was going to contact the consumer for additional troubleshooting, but no further complications were reported.

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 MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 5915071
• MDR Text Key: 53505990
• Report Number: 3004209178-2016-17899
• 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: Initial,Followup,Followup,Followup
• Report Date: 04/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/15/2017
• Date Device Manufactured: 09/09/2013
• 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 Age: 72 YR