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

Model Number 37714

Device Problems Energy Output To Patient Tissue Incorrect (1209); Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

Patient Problems Arrhythmia (1721); High Blood Pressure/ Hypertension (1908); Nausea (1970); Pain (1994); Respiratory Distress (2045); Therapeutic Effects, Unexpected (2099); Tingling (2171); Complaint, Ill-Defined (2331); Electric Shock (2554)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The patient reported that their implantable neurostimulator (ins) had failed but they did not know what failed meant.The stimulation would hurt when the patient turned it on and they would have to keep trying to adjust it for half an hour.Sometimes it was really good but sometimes it felt like they had kidney stones.The patient would turn off their stimulation and have to get it adjusted again.The ins was giving them a quarter of pain relief which is why the patient thought it was left in.The patient noted that when the stimulation was on it made them want to vomit but that feeling would go away when the stimulation was off.The patient also had an ongoing shocking event when they recharged their ins and a history of zapping in their legs.The patient also felt a shock when they opened their arms to hug or perform an activity.The ongoing shocking event started in (b)(6) 2016 and the date of the shocking in the legs was unknown but noted to possibly be the summer of 2014.The patient was not taking oral medication as the oral medication had given them side effects.The patient tried to charge once and immediately could not breathe.The patient thought they were shocked in their chest down their left arm into 2 fingers.The patient called their doctor and was told that they may be having an arrhythmia and to call 911.The patient went to the emergency room as they had an outrageous heartbeat.The paramedics gave the patient something under the patient's tongue and they did not know what the issue was.The patient was also given 4 aspirins.When the patient got to the emergency room their blood pressure was 187/116 and it kept going up and up.The patient was not charging the next day and still got shocked when they opened their arms to hug someone.The patient felt like the stimulation was on and thought maybe it turned on for some reason.The patient was also feeling tingling sensations.The patient also had excruciating pain at their ins site.They had been off all medication for 3 weeks and the night prior to the report they experienced the pain at the ins site.The patient took a percocet for this pain.The patient did not want to troubleshoot at the time of the report and was 100% sure the device was turned off.The patient was implanted for complex regional pain syndrome type i and spinal pain.No causes or interventions were reported with this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow-up report will be sent.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.

Event Description

Follow up information received from the healthcare professional (hcp) reported that the patient's ins was removed on (b)(6) 2016.Notes associated with the explant procedure reported the patient felt shocks from the device.It was reported that the patient was alive and well at the time of the device removal.There was no indication that another device was implanted.Additional information received on (b)(6) 2016 from the hcp reported that, as troubleshooting and diagnostics performed, the patient had multiple doctor visits, the device was interrogated, and they saw a pain management.The cause of the shocking was not determined but the issue was reported as resolved.

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id: 3776-60, serial# (b)(4), implanted: (b)(6) 2010, product type: lead.Product id: 3776-60, serial# (b)(4), implanted: (b)(6) 2010, product type: lead.The ins (serial # (b)(4)) was returned and analysis found that the stimulation ins battery had reduced capacity due to overdischarge.

• Brand Name: RESTORE SENSOR
• 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 NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5464465
• MDR Text Key: 39484159
• Report Number: 3004209178-2016-03600
• 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
• Report Date: 12/12/2016

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: 02/28/2014
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/01/2016
• Initial Date FDA Received: 02/26/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/05/2016; 12/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2013
• 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 Outcome(s): Required Intervention