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 Problem (1431); Device Difficult to Program or Calibrate (1496); Inappropriate/Inadequate Shock/Stimulation (1574); Communication or Transmission Problem (2896)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Electric Shock (2554)

Event Date 05/16/2020

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 with an implantable neurostimulator (ins).It was reported that the patient contacted them because they noticed that adaptive stimulation didn¿t work.The patient tried to reset the positional settings, but the ins was not saving the parameters.They stated that all positional amplitudes were the same value and would not adjust with their position.Since the intensity would not adjust, the patient reduced the amplitude so it wouldn¿t be uncomfortable in some positions.But they stated that they were also not getting optimal therapy as a result.The rep indicated that the patient noticed this issue over the weekend (either (b)(6) or (b)(6) 2020).It was also noted that the surgeon had been talking about replacement with the patient.It was reported that the rep had an appointment scheduled with the patient on (b)(6) 2020 to review programmed parameters.Additional information was received from the rep on (b)(6) 2020, reporting that over the weekend the patient used their recharger to turn the ins off and on and then the as started working fine.The rep checked the as settings and they seemed to be setup fine.Technical services had the rep change the lying to upright transition time.It was noted that the patient would go home and use the system to see if the as was working now.No further complications were reported/anticipated.Additional information received from the manufacturer representative reported that they were unable to determine why the adaptive stimulation didn¿t adjust to the settings.The patient turned the stimulation off and then back on the morning of their meeting with the representative.The adaptive stimulation was working immediately after she did that.The patient was directed to contact the representative if this happened again.Additional information was received from the rep.Rep stated that when the pt would lay down, the stimulation setting from standing would be what was delivered even though the position would show correctly as lying.Tss asked the caller if he confirmed all the variables that would factor in (transition time, position settings, etc) and he said that was able to confirm--the caller said that all positions had amplitudes set to them and he was aware of how transition times would factor into what is displayed and delivered by ins.The pt has concerns with ins and that their stimulation perception may have changed (tss unclear if this was related to previous concerns though the caller seemed to place it in the context of initial issue) so the pt had an x-ray yesterday but the midlevel working with the pt advised that it doesn't appear leads have moved/migrated.Tss suggested caller to meet with the pt at least one more time since the clinic is now wanting to know if this is a defective ins that needs to be replaced.Tss advised caller to call tech services when with the pt to have another set of eyes to confirm that his suspicions are accurate.Tss reviewed mdt file may be pulled and also noted that if they do decide to replace the ins that the current device should be sent back for analysis.Caller mentioned that the pt took a video of her as situation.Additional information from rep stated that over the weekend the pt used the insr to turn the ins off and on and then the as started working fine.Rep checked the as settings and they seem to be setup fine.Ts had rep change lying to upright transition time.Pt will go home and use the system to see if as is working now.Additional information was received from the patient.It was reported that patient was having difficulty changing adaptive stimulation.The pt states for most of the day she is at 3.7v, but when she turns the stimulation up to 4.2v, all of her positions within adaptive stimulation change to 4.2v.When she lies down with the stimulation at 4.2v, she feels like she is getting "electrocuted".The pt inquired why it would do that.Reviewed adaptive stim w/ the pt and had the pt change the upright position from 3.8v to 4.2v.The pt confirmed that the as saved the upright position, but when she changed to the lying back position, the stimulation took time to go from 4.2v to 1.2v (1.2v is what the pt had the lying back settings saved to).The rep set the lag to 0 seconds so it shouldn't take this long for the ins to switch the level of stim.The pt tried the lying right position and reported it was 4.2v, when it should be 1.8v.The pt then proceeded to report that the lying back showed 4.2v (pss is unsure if the pt was still in the lying right position or upright position which was saved at 4.2v).During the call the pt mentioned the patient programmer (pp) had a hard time connecting, but was able to successfully sync the pp with the ins.Later, the rep reported that they wanted to do troubleshooting around as use and described what patient reported earlier.Tss reviewed functioning of as in case where pt makes changes to stim for one position but then moves into another position within 3 minutes of that change and that this will cause the stim to stay at that new level for new position (the system assumes that the pt wanted to make stim change to new position, not old position).Checked assigned values for positions using tablet and they were all correct.Then checked a few different scenarios making changes to stim using pp.Values were changing as expected.Pt indicated that she thinks the issue with as started because she had a change in her pain needs and had been making more frequent changes to stim and wasn't always staying for 3 min to reassign the new value, and therefore was assigning the intended level of stim to the wrong position.Pt understood this and agrees this is what was happening.Issue was resolved.No further complications were reported/anticipated.

• Brand Name: RESTORE SENSOR
• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10104645
• MDR Text Key: 193025064
• Report Number: 3004209178-2020-09423
• 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: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/01/2020

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: 08/14/2013
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/18/2020
• Initial Date FDA Received: 06/01/2020
• Date Device Manufactured: 09/21/2012
• 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