MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number 97714

Device Problems Failure to Deliver Energy (1211); Failure to Interrogate (1332); Charging Problem (2892); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Date 11/10/2014

Event Type  malfunction  

Event Description

It was reported that stimulation was in the wrong location.Burning sensation was reported.It was reported that the patient is having a hard time with the stimulator.The patient reported that they were not getting any pain relief.For the first week, the patient had pain relief but then had a fall and since the fall, has not been getting relief.The fall was around (b)(6) 2014.It was reported that they are getting stimulation but not getting rid of the pain.The stimulation was totally different from after surgery and it is in a different area.The patient has been to their physician twice and they haven¿t been able to get therapy.One week ago, they saw their physician and couldn¿t get it effective with pain especially when sitting which is unbearable but a little less walking.An x-ray was performed but has not gotten the results.The patient was getting stimulation a little in buttocks and left hip area up to waist, and right leg down towards lower calf.The stimulation was initially in the buttocks and pelvic area, no stimulation in legs, and the patient was pain free.It was reported that it has been totally different since the fall a couple of weeks ago.The patient was adjusted and it worked great for the first day and then woke up the next morning to find it not working again.It was fixed a little bit so the patient could at least walk with less pain but sitting is unbearable.The patient reported that they also have a burning sensation at the implant location.It was reported that it is tender when device is off, when they lay on their back, or sit in a chair that the pressure causes it.It makes the implant location feel hot and stingy.There was a recharging issue since sunday.A coupling problem was reported.The patient can¿t get back to 6 boxes and this has been happening since sunday.An antenna locate feature was done and the patient was getting about 88.After being fully charged the device lasts 18 hours before going to half.While patient was on the phone with a manufacturer representative, they couldn¿t get it to work.The patient was told to charging without the belt.The patient is now getting 0 boxes shaded and no longer getting 6 boxes shaded.It was reported that the patient was not moving while attempting to charge.With the belt, the patient was not able to get any coupling boxes shaded.When patient propped a pillow behind, they were able to get all boxes shaded and when doing the antenna locate (al) feature, they were getting 102.It was reported that they were not able to connect to implant.The patient has an appointment on (b)(6).No interventions or outcome were reported regarding 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

Concomitant products: product id 97754, serial # (b)(4), product type recharger; product id 97740, serial # (b)(4), product type programmer, patient; product id 977a260, serial # (b)(4), implanted: (b)(6) 2014, product type lead; product id 977a260, serial # (b)(4), implanted: (b)(6) 2014, product type lead.(b)(4).

Event Description

The company representative confirmed that the patient was seen and reprogrammed the second week in (b)(6).The patient has an appointment on (b)(6) 2014 to turn on the sensor activation.The patient was implanted for an off label indication.Patient has pain as a result of a pelvic mesh that was used during a previous surgery.The patient is very anxious, very high strung, and has/will need frequent repeated education.The patient did not fall, almost fell, just lost her balance.The device is run on high energy levels and charges every day.The patient was encouraged to break her charging up into two sessions daily.The device is working but patient anxiety and pain was a big issue.

Event Description

Additional information received reported that the patient received assistance from their doctor or manufacturer representative and their concerns were resolved.The appointment date was (b)(6) 2015-.

Manufacturer Narrative

(b)(4).

Event Description

A couple weeks later it was reported that the patient went to a store yesterday and the intensity of the stimulation got strong.Both legs went into spasms/convulsed, and the patient lost her balance; someone caught her.The patient turned the implantable neurostimulator (ins) off and then turned it back on 5 minutes later when she was over by where all the computers were, and the same thing occurred again.The stimulation ramped up from 3.5v to 7.0v on its own while at the store.The store told the patient the security was rf and felt it would not affect her device.After this occurred the patient could not recharge her ins.It was further reported that while walking in the store the patient noticed a surge on her stimulation and leg went into a convulsion and she fell over.Then the patient turned her stimulation off for about 10 minutes and turned back on.Synch button was used first.Another episode happened again after she turned her stimulation on at the store.The patient then kept her stimulation off during the store.During the report it was confirmed that the patient was able to advance to the main screen of the patient programmer (pp) and the ins was on.The patient had just turned it back on at the time of the report.There were no coupling bars so the antenna locate feature was performed, then the patient was able to get six coupling bars (normal amount of bars while recharging the ins was 6-8).The ins battery wasn't charged and the patient was charging the last of it.The burning at the ins site was getting worse than already reported, it was red hot and piercing now.It was noted the incision was still a little red.The burning has occurred since implant and when charging.The patient fell in the chair and another time had to squeeze between two boxes thinking she also squeezed the ins but again thought the burning had occurred prior to those incidences.The patient was riding in a car (not touching anything) and the stimulation increased, ramping up from 3.8 to 7 something.The patient was able to turn off the stimulation and an hour later turned the stimulation back on, it has been fine.The patient spoke to her doctor, who told her she may want to consider leaving it off until she is seen.The patient has an appointment on (b)(6) 2014.The patient was in too much pain to leave the stimulation off and it was currently on even though she was worried.A surging sensation occurred.While walking around at home the stimulation ramped up.The doctor suggested to charge less time, but more frequently; 1/2 hour in the morning and at night.Patient was also instructed to turn the stimulation off during charging.The patient as aware to use a thin material in between the recharger and skin.The patient keeps her pp antenna on her device at all times as she changes between groups based on her position.The ins has not been orientated nor has the adaptive stimulation been activated.At the patient's appointment the amplitude was at 4.2v, group a walking and group c sitting.Typically the amplitude was at 4.5-5.0v and a limit was set from 3.8v-4.5v.Electrode impedances were within normal range, 700-800ohms.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; 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: 4347895
• MDR Text Key: 5137895
• Report Number: 3004209178-2014-24315
• Device Sequence Number: 1
• Product Code: GZB
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/02/2014

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: 08/28/2015
• 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: 01/26/2015
• Initial Date FDA Received: 12/19/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 12/23/2014; 01/21/2015; 01/29/2015
• Date Device Manufactured: 10/01/2014
• 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: 00067 YR