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

Model Number 97714

Device Problems Energy Output To Patient Tissue Incorrect (1209); High impedance (1291); Unintended Collision (1429); Therapy Delivered to Incorrect Body Area (1508); Device Operates Differently Than Expected (2913); Improper Device Output (2953)

Patient Problems Bruise/Contusion (1754); Undesired Nerve Stimulation (1980); Device Overstimulation of Tissue (1991); Pain (1994); Therapeutic Effects, Unexpected (2099); Urinary Retention (2119); Anxiety (2328)

Event Date 06/01/2017

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 patient with an implantable neuro stimulator (ins) for non-malignant pain and chronic low back pain on (b)(6) 2017.The patient stated that his ins was coming up with this weird thing.The patient stated it was fine when he turns it on but when he turns it off he still felt stimulation in his right and left for 7-10 minutes.The patient stated it was the ins that was supposed to keep his heels from hurting.Product service specialist (pss) redirected patient to health care professional (hcp).No further patient symptoms or complications were reported in this event.Additional information was received from a consumer and a manufacturer's representative (rep) on 2017-07-06.It was reported that the patient called back as they hadn't heard back from the field employees.The patient elaborated ion the event they had already reported and said the stimulator was not shutting off fully when they lay down horizontally, as they get stimulation for 20-30 minutes before it shut off.The patient stated that they are not getting a response for anyone.The patient was told to have their healthcare provider (hcp) page a manufacturer's representative (rep) as it would allow for the quickest response.The patient had called again and stated that they would feel stimulation after the device showed it was off.A manufacturer's representative (rep) contacted the patient and was set to meet with them.Additional information received from the consumer on 2017-07-20.The patient reported that they didn¿t know why the unit was not shutting off completely.The patient noted that the stimulation issue had not been resolved at all.Additional information was received from the patient on 2017-07-19.It was reported that the patient was at the hcp¿s office and a rep just happened to be there at the same time.The rep checked the ins, reset it, and said it was working properly and not faulty.The rep stated that the patient must have jarred something with his body and the patient was redirected to a ¿neuro guy¿ to see what he could do neurologically to make the stimulator correlate with what it was.The patient noted that he could live with it because it is just what it is.The patient stated that stimulation didn¿t seem to shut off when he shut it off.It seemed like it took an hour or two to completely shut down before he didn¿t feel it.The patient needed to make sure being going to be and lying horizontal, sitting in his recliner, or getting horizontal because he needed to shut it off an hour or two before.The patient noted that he had lowered the setting, but that prior to the meeting with the rep it was at a higher setting.The patient had two previous stimulators implanted and when he shut them off they went off.The patient was scared that his current stimulation wouldn¿t shut off at all and that he couldn¿t sleep at all or lie down at all.Once it was on and got stuck in the on position; it seemed stuck in the horizontal position and was too intense which was why the patient turned stimulation off when he drives.The patient was worried about it stimulating after it shut off because it never happened with any of his stimulators in the past, and it worried the patient that he might not be able to turn stimulation off.It would shut off, and the patient knew that now.The rep told the patient that it may take a little time with the residual effect and that the patient didn¿t have to worry about it stating that it may take a little time, but that it would go off.The patient was physically seeing that the stimulation was off, but didn¿t feel it.It took anywhere from half an hour to two hours before it felt like it turned off.Issues with stimulation when he fell down on his left side began in (b)(6) of 2017, not more than a month prior to (b)(6) 2017.The ins was on the patient¿s left hip.The patient seriously hurt his shoulder, thought he broke it, and it was all black and blue.The patient went to see the shoulder doctor and it had been about four weeks since the patient saw the hcp as of (b)(6) 2017.A day or two later the patient noticed that when he was shutting the stimulator off that it was not shutting off.It always shut off before, but now it did not.The patient was worried about a lead issue or fracture and that was the reason for the rep checking the ins.No further complications were anticipated.Additional information was received from the consumer on 2018-01-31.It was reported that the ins had not been working correctly since the fall.The patient said the stimulation was not in the right place and was not shutting off completely.The patient said he met with a manufacturer representative on (b)(6) 2017 and the representative checked the device and said it was working properly, but it was possible the fall may have caused a wire to move, which was why he was not getting coverage.The representative adjusted stimulation so it covers better than it was.The patient said after the representative changed the setting the coverage got somewhat better.The patient fell 4-5 months ago on his left side.The device is in the patient¿s left hip.The patient hurt his shoulder, but he did not hurt his hip too badly.The patient said his whole left side was black and blue from his hip to shoulder.The patient mentioned he is on blood thinner.The patient said when he shuts the device off at night, he can still feel stimulation.The patient was redirected to their healthcare provider to address residual stimulation any physician listings were sent.No further complications were reported/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.It was reported that at the time, patient had and appointment set for (b)(6) 2018 to see a pain management team to see if they would take care of the pump fillings and they said they have a surgeon in their group that was very good with the unit.The stimulation issue was not resolved at the time.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information received from the rep reiterated the report of the fall/stimulation not turning off right away.The stim would stay on for a minute or 2 after programming the device off.It was reviewed that the rep could try to change the softstart on/off time to see if that makes a difference.It was also reviewed that imaging could be used to check for migrations/changes.The rep also reiterated that one electrode had impedance >10k ohms but that it was not being used in programming.The patient had no therapy changes since fall and was getting significant pain relief.When the stimulation stays on after programming it off, it distracts the patient and they are unable to go to the bathroom.No further complications were 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 via a manufacturer¿s representative (rep).The rep reported that the patient fell in 2017; he didn¿t know the date and couldn¿t provide details surround the fall because he didn¿t remember.The rep reported that the patient stated in the days following his fall, he noticed bruising around the neurostimulator (ins) site in his left buttock and since the fall, the device continued to run after her turned the ins off with his patient programmer.The rep reported that impedances were measured multiple times, all values were within range except electrode 3 which showed greater than 10,000 ohms consistently.The rep reported that no other values were out of range and the patient denied changed in stimulation or pain relief since the fall.The rep reported that the patient programmer was used to turn the device on and off and no issues were noted.No interventions were taken.It was unknown if the issue was resolved at the time of the report.No further complications were 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.It was reported that they fell on their left side and hurt their shoulder.The patient stated that their left side was black and blue after the fall.Afterwards, they noticed that the device was not working properly.The patient clarified that it was still turning on, but wasn¿t turning off.The patient stated that it would take 30-45 minutes for the ins to shut off, where normally they would press the button on the programmer and they would feel it turning off right away.The patient met with a manufacturer representative who tried to correct the issue.The manufacturer representative checked the unit and determined that it wasn¿t the stimulator itself that was the problem, but that maybe the patient hit a wire or something when they fell.The manufacturer representative told the patient that the device was working properly and tried to ¿fine tune¿ it so that it would help more.The patient also reported that the stimulation was going to their buttocks instead of their heels.It was noted that the stimulation wasn¿t supposed to be in the buttocks and although the patient was having pain there, that wasn¿t what they were implanted for.The patient stated that they were still having issues and mentioned that they were meeting with a new healthcare provider (hcp), as well as a manufacturer representative.An appointment was scheduled for (b)(6)2018.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 was received from a manufacturer's representative (rep).It was reported that the patient cancelled their appointment to have their system reprogrammed and declined to reschedule.The cause of the stimulation not turning off right away after being turned off was unknown.The cause of the high impedance is unknown.The high impedance is not resolved at this time.The rep met with the patient on (b)(6).It was reported that there was no data in the mdt file to think that the stimulator was staying on when the device is turned off.The patient uses their remote a lot (100 times) since (b)(6).It was reviewed that the patient may be attempting to turn stimulation off, but may in fact turn the device on.No further complications were reported or anticipated.

• Brand Name: SURESCAN
• 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: 7241222
• MDR Text Key: 99779812
• Report Number: 3004209178-2018-02063
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/17/2018

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: 12/14/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/31/2018
• Initial Date FDA Received: 02/05/2018
• Supplement Dates Manufacturer Received: 03/07/2018; 02/23/2018; 03/13/2018; 03/23/2018; 03/28/2018
• Supplement Dates FDA Received: 03/07/2018; 03/12/2018; 03/15/2018; 03/28/2018; 04/17/2018
• Date Device Manufactured: 01/22/2014
• 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 Age: 68 YR
• Patient Weight: 87