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 Intermittent Continuity (1121); Failure to Deliver Energy (1211); Overheating of Device (1437); Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885); Charging Problem (2892)

Patient Problems Nerve Damage (1979); Pain (1994); Therapeutic Effects, Unexpected (2099); Burning Sensation (2146); Complaint, Ill-Defined (2331); Electric Shock (2554)

Event Date 11/03/2017

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 consumer regarding a patient who was implanted with a neurostimulator for stenosis.It was reported that the patient was not feeling stimulation and the device seemed dead but was fully charged.They said they adjusted the stimulation to 9 volts and were not feeling stimulation.The patient programmer said that the stimulation was on.The patient was assisted with changing to group f and the patient said that was not right but the stimulation was alive in their hip area; the patient changed back to group d.They said they had hip pain six months ago and they changed their settings.The patient also reported feeling warmth near the ins area.They were directed to their healthcare provider to address the issues reported.No further complications reported.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient and healthcare provider (hcp).It was reported that the patient had an appointment scheduled with their hcp on (b)(6)2017.No further complications are anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient and healthcare provider (hcp).The patient stated that their ins recharger (insr) was not working as of (b)(6) 2017.The patient clarified that they were referring to their patient programmer and their ins as previously reported.They stated that their ins was charged and that while they had 3 programs for stimulation, they normally only used one.The patient noted that if their ins was to be replaced, they would need to get the same program onto the new ins.It was reported that the patient had an appointment scheduled with their hcp on (b)(6) 2017.No further complications are anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient on 2017-dec-04.It was reported that the patient would usually experience a surge that would make them put their head down for a moment.The patient described it as that ¿it kind of sucks the wind out of you.¿ the patient stated that they had nerve damage in their legs and hips.In addition, they felt burning in the lower part of their back while on group f.No further complications were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information received from the consumer.The patient reported that they didn't have therapy and there was no change in activity level or programming changes.They stated that they had the stimulator set on high voltage and when they turned it on they received a jolt of stimulation.The program they had used, which was incorrect, was the one that went on once the battery was charged.The stimulator then started in their rib cage near their heart and the patient described it as a burning sensation for a couple seconds.The stimulator did something to their heart and they didn't like it or want it in that area.Their neurosurgeon recommended they get the stimulator because of the nerve damage in their legs that they had for years.They reported that the surge sensation had been resolved.When they were at home they found that the program they use was not working correctly, the stimulation had totally moved to an incorrect area.They had an appointment on (b)(6)2018 for programming.The loss of stimulation and warmth near the ins site had not been resolved.No further complications reported.

Manufacturer Narrative

Due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a consumer regarding a patient who was implanted with an implantable neurostimulator (ins) for spinal pain.It was reported that the patient was thinking the ins was replaced due to normal battery depletion but wasn't sure because when they had gone to charge the ins it had stopped charging.No further complications were reported or anticipated.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Additional information received from the patient reported that the cause of their nerve damaged was that their husband threw them and that this occurred in 1995.The cause of the warmth near the ins was not determined but that part of the pain in the lower back was resolved.The patient noted that they had only tried using group f after the ins was no longer working correctly then the ins died.The patient went on to say that group f did not work correctly.No further complications were reported.[omitted information pertaining to leg issues and inability to change group - see pe# (b)(4).

• Brand Name: RESTORE ULTRA
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR 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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7003368
• MDR Text Key: 92171029
• Report Number: 3004209178-2017-23207
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2011
• Device Model Number: 37712
• Device Catalogue Number: 37712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/03/2017
• Initial Date FDA Received: 11/06/2017
• Supplement Dates Manufacturer Received: 12/01/2017; 12/01/2017; 12/04/2017; 01/09/2018; 07/20/2018; 09/04/2018; 08/08/2018
• Supplement Dates FDA Received: 12/04/2017; 12/04/2017; 12/19/2017; 01/29/2018; 07/24/2018; 09/24/2018; 10/04/2018
• Date Device Manufactured: 09/29/2010
• 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
• Patient Age: 70 YR
• Patient Weight: 57