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 Overheating of Device (1437); Device Operates Differently Than Expected (2913); Inadequate Instructions for Non-Healthcare Professional (2956)

Patient Problems Bruise/Contusion (1754); Burn(s) (1757); Cellulitis (1768); Coagulation Disorder (1779); Fever (1858); Bone Fracture(s) (1870); Nerve Damage (1979); Pain (1994); Burning Sensation (2146); Ulcer (2274); Discomfort (2330); Complaint, Ill-Defined (2331); Numbness (2415); Skin Inflammation (2443); Burn, Thermal (2530)

Event Date 01/01/2015

Event Type  Injury  

Event Description

Information was received from a patient who was implanted with a neurostimulator for post lumbar laminectomy syndrome. It was reported that there was discomfort while charging as the implantable neurostimulator was too hot. There were a lot of heat problems from charging the device. The implantable neurostimulator/implantable neurostimulator pocket gets really hot during recharging. The patient reported that it burns her, and that she can only charge it half way because it burns her. The implantable neurostimulator battery inside her is hot all the time and the patient stated, it feels like you have a fever all the time. The patient wakes up in the morning with a great big blister. The burning sensation goes away when the stimulation is turned off. The patient has ulcers on her buttock and hip area, loses feeling her fractured foot and developed cellulitis in her feet from the stimulation heat and the caller was in the hospital not too long ago. The stimulation possibly caused nerve damage in the patient's foot/leg. The patient's foot has been operated on many times and the toenails have been taken off. The stimulation was currently at 1. 65 volts and it was driving her crazy. The stimulator has been a life saver and does help with her pain. As intervention, the manufacturer representative advised the patient to turn stimulation down and only charge it half way or recharge every 30 minutes. The patient reported that she was having an mri for other medical issues described as blood not clotting and bruising all over and a fractured foot. The patient reported that nobody told her before she was implanted that she could only have an mri of the head. The exact date that these issues started occurring is unknown, but the patient knows that they started sometime after 2015.

Manufacturer Narrative

Corrected information: sex, date of birth.

• Brand Name: RESTORE ULTRA
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5650475
• MDR Text Key: 45033169
• Report Number: 3004209178-2016-09373
• Device Sequence Number: 1
• Product Code: LGW
• 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

• Type of Report: Initial,Followup
• Report Date: 05/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/14/2011
• Device Model Number: 37712
• Device Catalogue Number: 37712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/18/2016
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 11/23/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 05/12/2016 Patient Sequence Number: 1