| Model Number 97702 |
| Device Problems
Electromagnetic Interference (1194); Migration or Expulsion of Device (1395); Overheating of Device (1437); Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Burn(s) (1757); Fall (1848); Muscle Weakness (1967); Burning Sensation (2146); Discomfort (2330); Complaint, Ill-Defined (2331)
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| Event Date 07/09/2015 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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Information received from the patient reported that they had pain at the site of their implantable neurostimulator (ins) which occurred daily since (b)(6) 2015.The patient stated that it was really sore and hurting.There were no falls or trauma reported.On (b)(6) 2016, the patient saw their healthcare professional (hcp) where it was confirmed, per mri, that the device was in place.They also saw the manufacturer's representative for reprogramming.The patient noted that the hcp gave them "oil and an si injection." this gave them one day of relief and hasn't helped.The doctor told them that the site was healed but the patient stated it felt like the back side was not healed.The patient stated the doctor won't do anything.Follow up information received on (b)(6) 2016 from the patient reported that for about 2 months they would get some relief but then about 2.5 months the pain got worse.About 3 months ago they woke up at 5 am with pain across their back (3 inch wide area).They turned the ins off from 9 pm to 9 am.The patient's right leg was weak and they had to use a cane/walker.The patient's physician did an epidural and the second day got relief (one day of relief).Later the physician did an injection that gave the patient no relief.The patient stated that the ins still felt "raw" on their back side (the ins was implanted in the lumbar area).They noted that they had leg pain but stated that it was the implant itself that hurt.The doctor stated that it was healed and they had no answer why it hurt the patient so bad.The patient was told to try "emvoil" but had no results with that.They also mentioned ice, heat, "imvoil," apsercream with lidocaine treatments.They could not take pain medications.The patient stated again that there were in a lot more pain since implant, that the implant itself hurt ("was sore"), and noted "this was my last resort." a family friend told them it was the best thing since "bubble gum." the patient had no change in activities.The patient saw a new doctor and they were waiting for orders for a different epidural and lumbar mri.They were thinking about a pump and had serious doubts regarding the ins therapy because of their experience with it ("worse decision i ever made").The patient stated that they would remove it if it were possible.Additional information received from the patient on (b)(6) 2016 reported that they had deep femoral hernia surgery and exploratory surgery where one staple was removed and on nerve was clipped.The patient stated they were in more pain than before the implant of the ins.They also had an mri of the thoracic area.The doctor was checking to see if "it" was in place and a second doctor noted the "thoracic" was useless.The patient was to get a second opinion and was to have an mri and 3 x-rays on (b)(6) 2016.The physician was also supposed do an epidural injection.The patient stated had one epidural injection already but was to be getting a different kind.The indication for use for the implanted device was noted as spinal pain.There were no further details, troubleshooting, interventions, or an outcome was 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.
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Follow up information received from the patient reported that they got a second opinion and the doctor ordered 3 x-rays and a lumbar mri.The patient got an epidural injection and it was "three shots." it was noted that the first doctor did a thoracic x-ray and not a lumbar.They then had 2 more x-rays which showed the implant was rubbing on the bone.The patient stated that they had been through "nothing but (profanity)" for 9 months.They had been sore for 8 weeks after implant surgery and had more pain since.The patient was schedule to see the surgeon on (b)(6) 2016 and mentioned that now need another surgery "when a simple x-ray would have solved the problem." if additional information is received, a follow-up report will be sent.
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information received from the patient confirmed that the x-ray showed that the ins was rubbing against the pelvic bone which caused them 6 months of "profanity" and worsening pain at the ins site.They had more pain than before the implant of the device.The patient stated that they did not want another surgery and was hoping to have the therapy reprogrammed to cover the additional pain.
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Manufacturer Narrative
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Concomitant medical products: product id 977a260, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2016, product type: lead.Product id 977a260, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2016, product type: lead.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received from the patient.It was reported that the patient¿s ins was causing pain and burning.The patient had her device taken out on (b)(6) 2016 because the device was causing her a lot of pain that she could not stand.The implant doctor put the device on her pelvic bone and it was ¿killing¿ her.Since being implanted the device caused her a terrible discomfort and pain.The patient waited for six months and finally told them.The patient kept asking the implant doctor why the ins was in the lumbar area and the doctor did an mri of the thoracic spine instead of lumbar spine.When the patient went to another healthcare professional (hcp), that hcp said that her mri was useless.The implant doctor told the patient ¿well, maybe you are fat¿.The patient said that she did not have enough fat and that she weighed (b)(6) at that time.When the patient saw the implant doctor the last time she asked him why she was hurting so much and he said ¿with your history, i have no idea ¿ have you tried emu?¿.After the implant doctor dismissed the patient she called the manufacturer who sent her hcp listings to go get a second opinion.On (b)(6) 2016 a doctor repositioned her device.A manufacturer representative (rep) said that the battery was still good and they would not place a new ins.Right after the surgery on (b)(6) 2016 the patient started feeling a burning sensation.The intensity was where the wire went into the spine.The patient then went to see another doctor.He contacted the manufacturer and said it was time to take it out.There was nothing else the hcp could do.They took it out.The patient was not sure if a rep was at her last surgery.The patient also mentioned that she was told by her hcp at the beginning that the rechargeable ins would probably burn with mri but this one burned and it was a battery operated one.The patient stated that her ins was taken out on (b)(6) 2016 and she had so much relief on (b)(6) 2016, even though she now had pain down her leg.She also stated she felt sore on (b)(6) 2016 in the area where the ins/incision was from the explant surgery.The pain the patient had before was now gone.The patient had 13 months of pain.The pain was three times more than the pain the device was supposed to take care of.The patient did not know what the hcp did with the device.The patient asked for the device and the hcp told her the law did not allow them to give it to her.The patient was not to see the hcp until (b)(6) 2016 and would follow-up with the hcp.The patient did not remember when she notified the manufacturer and did not know if she ever mentioned burning to the manufacturer.Additional information was received from the patient.It was reported that the patient was still feeling a burning sensation.The burning sensation was right where the implant was and was about the size of a silver dollar.The patient was to follow-up with a hcp and had a follow-up appointment on (b)(6) 2016.At 3 am on (b)(6) 2016 the patient felt a sensation that felt like an ice pick stuck her just below the incision.A date of (b)(6) 2016 was given for when the burning sensation began which conflicts with the patient¿s previous report that the burning sensation began after the ins repositioning on (b)(6) 2016.It was noted that a doctor said the previous mri had showed everything was in place.The patient said that the doctor told her that her fat probably moved the device.The patient reported that she weighed (b)(6) at the time, conflicting with the previous report of (b)(6).Additional information was received from the patient.It was reported that she was practically crippled and still had leg pain despite the device being removed.The pain had continued after the physician repositioned the device on (b)(6) 2016.The patient was still having the burning as of (b)(6) 2016 when she sat down and was falling down all the time.It was noted that the patient had received a call from a rep who stated that the ins was destroyed by the hospital.It was also noted that the patient had vision issues, macular degeneration, for the eleven years prior to (b)(6) 2016.The patient was having more pain from the implant than before it was placed.The pain and burning was at the site where the ins and leads were.It was noted that the spinal cord stimulation therapy did not help the patient.
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Manufacturer Narrative
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Date of event was corrected to (b)(6) 2015.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received from the patient.The patient was still experiencing the burning sensation at her implant site as of (b)(6) 2016 and it felt like her implant was still there even though it was already explanted.The patient saw her primary care physician who recommended physical therapy.The patient's original managing hcp told her that they would not work with her because she had too many injections.
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Event Description
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Additional information was received from a patient on (b)(6) 2017.The patient repeated previously reported information including that on (b)(6) 2016 they called and asked how long it was supposed to hurt after the implant.The patient then stated, ¿how about 6 months¿.The patient was redirected to their healthcare professional (hcp) and was given a listing of hcps.The patient went for a second opinion and the hcp told the patient that the mri that the patient¿s previous hcp took was worthless because they took it of the thoracic area, but the implantable neurostimulator (ins) was in the lumbar area.They had to reposition the ins because the previous hcp put it against the patient¿s pelvic bone.Repositioning the ins did not help so they finally had to take it out.The patient was still suffering from pain as much as if the ins was still there.No further complications were reported/are anticipated.
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Event Description
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Additional information was received from a hcp on (b)(6) 2017 reporting that the patient had first been seen on 2016-03-23 with a weight recorded as (b)(6).The patient was last seen on (b)(6) 2016 with a recorded weight of (b)(6).Additional information was received on (b)(6) 2017 from the consumer in response to a follow-up letter that had been sent by the manufacturer.It was reported that the patient could not remember their weight at the time of the event but they had been (b)(6) at one point and (b)(6) at her heaviest weight.It was reported that the patient was currently having horrific back pain and thought that "they" messed up the patient¿s back when the implant was removed.It was stated that it felt like 2 vertebrae are rubbing.It was reported that the health care professional (hcp) wanted to do injections for this.It was re-reported that the patient had vision problems.It was mentioned that the patient had pain in their groin and sciatic nerve, which was the reason for implant.No further complications were reported.
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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