MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. RESTORE SENSOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 37714

Device Problems Energy Output To Patient Tissue Incorrect (1209); Energy Output Problem (1431); Overheating of Device (1437); Unexpected Therapeutic Results (1631)

Patient Problems Pain (1994); Burning Sensation (2146)

Event Date 04/27/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a patient with an implantable neurostimulator (ins) for spinal pain.The patient stated that they do not run it constantly but they have had a lot of back pain right now which starting flaring up about 2 months ago.They have burning and extreme pain at the implant site so that it why they do not use it constantly.This also began about 2 months ago.The patient was calling patient services because they are having residual stimulation even after turning the stimulation off for several hours.The patient has not had the stimulation on for 2 days yet but they can still feel residual stimulation in their leg and hip area.It has been happening for about a week now.They called their manufacture representative (rep) who called them back to setup an appointment but the appointment was never set up and the patient never kept up on it either.Patient services sent the patient a physician listings to follow up with.No further complications were reported/are anticipated.

Manufacturer Narrative

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

Event Description

Additional information received from the patient on (b)(6) 2018.The cause of the burning at the ins site was not determined.The cause of the residual stimulation was also not determined.The patient is going on (b)(6) 2018 to check with a new rheumatologist and neurologist first and then will proceed from there.The patient is just tired of doctor visits.Their issues are still occurring.They do not use continually.Only with severe back pain and not all day.They are always worried about draining the battery.Many days they do not turn it on but still will feel it as if it is on.The patient noted that their trial in (2009?) was amazing but their permanent one has not been pleasant.No further complications were reported/are anticipated.

Manufacturer Narrative

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

• Brand Name: RESTORE SENSOR
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR 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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7660846
• MDR Text Key: 113185600
• Report Number: 3004209178-2018-14987
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00613994610430
• UDI-Public: 00613994610430
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2017
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 02/24/2016
• 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 Age: 53 YR