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MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
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| Model Number 3058 |
| Device Problems
Use of Incorrect Control/Treatment Settings (1126); Migration or Expulsion of Device (1395); Therapy Delivered to Incorrect Body Area (1508); Malposition of Device (2616); Device Operates Differently Than Expected (2913)
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| Patient Problems
Abdominal Pain (1685); Diarrhea (1811); Nausea (1970); Undesired Nerve Stimulation (1980); Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Urinary Frequency (2275); Discomfort (2330); Complaint, Ill-Defined (2331); Sleep Dysfunction (2517); Abdominal Cramps (2543)
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| Event Date 07/05/2017 |
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Event Type
Injury
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Manufacturer Narrative
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Information references the main component of the system and other applicable components are: product id: neu_unknown_lead, serial# unknown, 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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Information was received from a consumer regarding a patient who was implanted with a neurostimulator.It was reported that the patient was feeling stimulation in the wrong location, painful stimulation, and uncomfortable stimulation.The patient stated that right after surgery they were feeling stimulation in the rectum and not in the vaginal area.The patient stated the doctor said to try it over the weekend but the patient still said it was in the rectum area.The patient stated they told the medtronic representative in the recovery area when they turned the stimulation on and the patient could tell by the look on their face that something wasn't right.The patient stated on july 10, 2017 they saw the representative again and they reprogrammed but it was still in the rectum and whenever they reprogram it, it just gets further away instead of closer to the area it¿s supposed to be at.The patient stated that for the past 3 nights they had been having excruciating pain and diarrhea and that was not normal.The patient stated that it was always after then slept for 2 hours and they couldn't sleep because it felt like a ping pong ball or something was tapping on their butthole.The patient stated that their stomach hurt so bad it was like they drank a gallon of milk if they were lactose intolerant and the patient¿s mom almost had to take them to the hospital.The patient also stated they had been having frequent urination and first noticed 4 days before the report and said they go about 12 times a day.The patient was redirected to follow up with their healthcare provider.No further complications were reported.Additional information was received from the patient.It was reported that right after surgery patient knew it was not stimulating the right area and was in their rectum, but they did not adjust it.Patient confirmed it was an uncomfortable stimulation in their rectum and stated they did not sleep the first night and for days they could not sleep.Patient's doctor helped adjust stimulation over the phone where it was more comfortable, but stated it was still terribly uncomfortable.Attempts to relocate the sensation were unsuccessful and they had an x-ray and all 4 of the programs were not in the correct area, and clarified that the leads were not in the correct spot.It was noted patient was on p3 because it was the most comfortable.Patient had terrible diarrhea because of where it was implanted and it was stimulating their bowels.Patient mentioned they had an upset stomach and stomach cramps and pain, and they were still having all their bladder problems so they turned off their stimulator.Even though stimulator was off, patient was still uncomfortable and stated they constantly 'squinched in their butt/rectum area, like squinching a penny between their butt cheeks'.Patient mentioned the incisions were fine, but that they were sitting on a soft bed but felt like they were on a hard surface.Patient had no relief of their bladder symptoms.No further complications were reported.
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Manufacturer Narrative
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Section d information references the main component of the system and other applicable components are: product id 3889-28 lot# va1gzvl (b)(4).Implanted: (b)(6)2017 explanted: (b)(6)2017 product type lead.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 consumer.It was reported that had a revision on (b)(6)2017 and did not want to talk about it anymore.Patient stated that they felt like someone was punching them in their butt and was having a little bit of discomfort.Patient reported that they had tried adjusting stimulation and was on a program that works best for them patient stated they were having back pain , further mentioning the whole right buttock, and could not sit for very long because it was uncomfortable.Patient also noted that they were told that they would not be able to feel the device through their skin but was scared it would come out and stated that they thought they could feel it.Patient also stated that they returned to work a day prior to the report, and has a very active job, and 2-3 times , all of a sudden they had felt pain where the device was, further stating that the pain was dull and not sharp.Patient wanted to know when symptoms would pass and when they could begin strenuous exercise again.Patient was redirected to follow up with the health care provider (hcp) regarding the symptoms reported, and they said they would be seeing the hcp the following day.No further patient complications were reported or anticipated as a result of this event.
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Manufacturer Narrative
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Other applicable components are: product id: 3889-28, lot# va1gzvl, implanted: (b)(6) 2017, explanted: (b)(6) 2017, product type: lead.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 a healthcare professional (hcp).It was reported that the cause of the stimulation in the wrong location was not determined.The patient was scheduled for a revision and the device was turned off after the intervention was unsuccessful.
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Manufacturer Narrative
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The main component of the system and other applicable components are: product id: 3889-28, lot# va1gzvl, implanted: (b)(6) 2017, explanted: (b)(6) 2017, product type: lead.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 via the manufacturer's representative (rep).It was reported that the patient was not getting relief, and had uncomfortable stimulation.It was unknown if there was any environmental/patient factors that may have led or contributed to the issue.It was reported that reprogramming and impedance checks had been done to try and resolve the issue.The rep noted that there was a lead revision but it was unknown if the issue had been resolved at the time of the report.No further patient complications were reported/ anticipated as a result of the event.
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Manufacturer Narrative
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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.Patient was considering device removal and since she was stuck with the device, until she can come up with enough money to pay her deductible, is there any way for the manufacturer to come up with her deductible because she was suffering terribly and does not have the money to come up with it.Patient said she had the trial on left side that worked well for her but when they did the implant surgery they said they got better response on right side.However, patient did not feel stim in bike seat patient felt stim in her rectum.Patient reported knowing as soon as woke up something was wrong there was no relief from symptoms.Patient stated, the next day she was on the phone with the hcp and went back and an x-ray was done, and patient was told that this was not where it was supposed to be.The hcp did a revision but still did not putit on the left side, they told her they got good responses on the right, but patient wanted to do another trial and try the left side.Patient said she had one of her hcp¿s associate do it.Patient reported that it did not work then either so now patient wanted to get it removed and be done with it because the pain was causing a lot of discomfort and the patient couldn¿t take it anymore.Patient reported in (b)(4)(2017) patient went back and they did an x-ray and the hcp reported that it was supposed to be 1 and 4 and it was 2 and 2.The hcp drew a picture where the leads were, and they were off again.Patient said she had to turn it off in feb because it was making her symptoms worse not better and causing a lot of pain and discomfort mostly in her tailbone area and right buttock.Patient reported suffering terribly.Patient was having really bad pressure and she felt sensations that go down right legs/ right buttock area.Patient reported feeling sore, patient felt like someone punched in her bum.No trauma/falls were reported that could be related to this issue.Patient said she had tried all of the 4 settings and tried new settings, patient had tried everything.Patient was upset about it not been working.Patient reported she was now considering botox.Patient said when she was just sitting, she could feel it down to the back of her knee.Patient reported it was not every day constant pain, but the pain and pressure in her tailbone bothers the most and patient cannot sit in any position for very long she had to constantly shift her weight, could not sit comfortably.Patient reported the device was kind of large, larger than she thought it was going to be.Patient reported that it just felt like she had a tickbed.Patient said aleve and tylenol were not helping they gave her a low dose of percoset and that did not do anything but at least it was something.
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Manufacturer Narrative
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Due to new information and imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated.Review of new information determined that some information previously reported in this report should have been captured in regulatory report #3004209178-2019-07356 instead as it occurred with the revised lead, not the lead associated with this event.The full description of this revised event is provided if information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a consumer regarding a patient who was implanted with a neurostimulator (ins) for gastrointestinal/pelvic floor and urinary dysfunction/sacral nerve stim.The patient reported she was feeling stimulation in the wrong area.Patient stated she was feeling stim in the rectum and she like to know where exactly she was supposed to feel the stimulation.Patient stated she was doped up with medication during surgery and she couldn't tell hcp where she was feeling the stimulation.Patient stated rep was present during the surgery and did the programming and asked where was feeling stim and she told rep she was feeling stimulation in the wrong area.Patient reported she have gone to hcp office¿s and they did reprogramming and she was still feeling stim in the rectum, it was uncomfortable, sore and felt like something was coming out of her butt, or she was sitting on a golf ball and she could not sleep since she has had the implant.Patient stated she was getting therapy relief, therapy was helping her but she goes to the bathroom sometime.Patient stated the trial was perfect and she slept for 7-8hrs straight at night and that was unheard of for her.On 2017-jul-12 information was received from a consumer regarding a patient who was implanted with a neurostimulator.It was reported that the patient was feeling stimulation in the wrong location, painful stimulation, and uncomfortable stimulation.The patient stated that right after surgery they were feeling stimulation in the rectum and not in the vaginal area.The patient stated the doctor said to try it over the weekend but the patient still said it was in the rectum area.The patient stated they told the medtronic representative in the recovery area when they turned the stimulation on and the patient could tell by the look on their face that something wasn¿t right.The patient stated on (b)(6) 2017 they saw the representative again and they reprogrammed but it was still in the rectum and whenever they reprogram it, it just gets further away instead of closer to the area it¿s supposed to be at.The patient stated that for the past 3 nights they had been having excruciating pain and diarrhea and that was not normal.The patient stated that it was always after then slept for 2 hours and they couldn¿t sleep because it felt like a ping pong ball or something was tapping on their butthole.The patient stated that their stomach hurt so bad it was like they drank a gallon of milk if they were lactose intolerant and the patient¿s mom almost had to take them to the hospital.The patient also stated they had been having frequent urination and first noticed 4 days before the report and said they go about 12 times a day.The patient was redirected to follow up with their healthcare provider.Additional information was received from the patient on 2017-jul-19.It was reported that right after surgery patient knew it was not stimulating the right area and was in their rectum, but they did not adjust it.Patient confirmed it was an uncomfortable stimulation in their rectum and stated they did not sleep the first night and for days they could not sleep.Patient's doctor helped adjust stimulation over the phone where it was more comfortable, but stated it was still terribly uncomfortable.Attempts to relocate the sensation were unsuccessful and they had an x-ray and all 4 of the programs were not in the correct area, and clarified that the leads were not in the correct spot.It was noted patient was on p3 because it was the most comfortable.Patient had terrible diarrhea because of where it was implanted and it was stimulating their bowels.Patient mentioned they had an upset stomach and stomach cramps and pain, and they were still having all their bladder problems so they turned off their stimulator.Even though stimulator was off, patient was still uncomfortable and stated they constantly 'squinched in their butt/rectum area, like squinching a penny between their butt cheeks'.Patient mentioned the incisions were fine, but that they were sitting on a soft bed but felt like they were on a hard surface.Patient had no relief of their bladder symptoms.No further complications were reported.Additional information was received from the patient via the manufacturer's representative (rep) on 2017-jul-27.It was reported that the patient was not getting relief, and had uncomfortable stimulation.It was unknown if there was any environmental / patient factors that may have led or contributed to the issue.It was reported that reprogramming and impedance checks had been done to try and resolve the issue.The rep noted that there was a lead revision but it was unknown if the issue had been resolved at the time of the report.Additional information was received from a healthcare professional (hcp) on 2017-07-26.It was reported that the cause of the stimulation in the wrong location was not determined.The patient was scheduled for a revision and the device was turned off after the intervention was unsuccessful.Additional information was received from the consumer on 2017-aug-16.It was reported that patient had a revision on (b)(6) 2017 and did not want to talk about it anymore.No further patient complications were reported or anticipated as a result of this event.On 2018-june-02 crts (b)(4) (con): see general text and (b)(4) ¿ no improv, discomfort, pain, explant for omitted info.Additional information was received.Patient said she had the trial on left side that worked well for her but when they did the implant surgery they said they got better response on right side.However, patient did not feel stim in bike seat patient felt stim in her rectum.Patient reported knowing as soon as woke up something was wrong there was no relief from symptoms.Patient stated, the next day she was on the phone with the hcp and went back and an x-ray was done, and patient was told that this was not where it was supposed to be.The hcp did a revision but still did not put it on the left side; they told her they got good responses on the right, however the issues were not resolved.No further patient complications are anticipated or expected as a result of this event.
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