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 Failure to Interrogate (1332); Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

Patient Problems Dehydration (1807); Fever (1858); Headache (1880); Pain (1994); Shock (2072); Tingling (2171); Distress (2329); Complaint, Ill-Defined (2331); Malaise (2359)

Event Date 02/18/2016

Event Type  Injury  

Manufacturer Narrative

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

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

Information was received from a manufacturer representative and a patient who was implanted with a neurostimulator for spinal pain. It was reported that the patient went on a trip to (b)(6) around (b)(6) 2014 and took stim with them. They were hooked up to some sort of generator and ever since the patient has come back, they have had problems. The problems have been medical in nature and not related to the device. It was reported that either the device inside the patient or her handheld device was not working. The patient noticed that it stopped working on the (b)(6) 2016 in the middle of a very bad attack of irritable bowel syndrome. The patient had been really ill, in a lot of pain, stressed, dehydrated, fever, and "a lot of stuff. " the patient said that she normally has back pain and her migraine which is constant and never go away. The patient had just left her pain therapy health care provider office on (b)(6) 2016 and she thought that her body went into shock when the device stopped working. Even now she feels like a humming/vibration when she gets up and moves. She noticed it ever since she stopped being ill. She normally has constant tingling in her feet that has gotten worse and goes from one foot to the other foot. The patient reported that she was still kind of ill at the time of the report. Additional information was received from the manufacturer representative on 2016-08-30 that reported that there was an alleged overdischarge. A physician mode restart was started, but about 3-4 minutes into it, they saw a 375 error code on the recharger. The patient had seen this code about a month prior to the report. About 6 weeks prior to the report, the patient stated that the recharger cord was bending a lot and the wire was starting to come out of the insulation so they put electrical tape on it to hold it together. Communication could not be established with the patient programmer, implantable neurostimulator recharger, or the clinician programmer. Within in the last 6 months, the patient has had difficulty charging as they have a hard time getting 6-8 coupling bars. The patient is able to charge the implantable neurostimulator and then it depletes quickly. There was not a spare recharger, so the manufacturer representative was going to meet with the patient again when they got the replacement implantable neurostimulator recharger antenna so that they could continue the physician mode restart. The manufacturer representative was also going to do further troubleshooting with the difficulty recharging and the quick implantable neurostimulator depletion. The patient's medical history includes that the patient is disabled with chron's disease and parkinsons. She has chronic pain and goes to a monthly appointment so that she can get her medication. Her spinal cord stimulation helps with the walking and everything else helps so that she does not have to use her cane. The patient also has fibromyalgia.

• 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: 5946333
• MDR Text Key: 101044152
• Report Number: 3004209178-2016-18789
• 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: company representative,consum

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 09/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/28/2012
• 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: 08/18/2016
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 09/01/2011
• 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: 09/13/2016 Patient Sequence Number: 1