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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
Intermittent Continuity (1121); Failure to Deliver Energy (1211); Energy Output Problem (1431); Loss of Power (1475); Therapy Delivered to Incorrect Body Area (1508); Self-Activation or Keying (1557); Unexpected Therapeutic Results (1631); Communication or Transmission Problem (2896); Insufficient Information (3190); Patient Device Interaction Problem (4001)
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| Patient Problems
Micturition Urgency (1871); Muscle Spasm(s) (1966); Undesired Nerve Stimulation (1980); Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Urinary Frequency (2275); No Code Available (3191)
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| Event Date 02/07/2018 |
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Event Type
malfunction
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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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Information was received from a patient regarding their implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.Patient said they were only feeling stimulation when connecting the antenna to the device.They were concerned stimulation would go away moments after the device/antenna was disconnected.They further questioned if the device was defective and their frequency "hasn't really improved" since implant; they were transferred to the call center.Patient further alleged the ins must be turning itself off because they can feel stimulation sensation at the target area (rectum) when they are "on-ing it." the call center inquired what the patient was referring to and reviewed patient programmer (pp) button functionality.The patient confirmed they have been pressing the "on" key on the left-hand side of their pp as the first action.On/off buttons on the left side of the pp was reviewed with the patient; the patient was unaware of this.With that being said, the patient says they never press the off button so they are not sure how the ins has been turning off.They are also unable to confirm if the ins was actually off before the sensation is felt; they are only assuming it has been off because they can feel stimulation after pressing the on button.Furthermore, the patient says they can feel stimulation unexpectedly after pressing the sync button; they would feel "like a contraction" at the targeted area that would last an hour and then go away.They also said it feels "like [they have] a hemorrhoid" when this occurs.It was reviewed that this is very unexpected because the sync button only gives a command to establish telemetry (the patient was not selecting a new program at this time; they were only attempting to sync with the ins).The patient confirmed this multiple times during the call; they confirmed stimulation was on at 1.2v on program 1.The patient is alleging the ins is defective because this has occurred since implant and the sensation is not dependent on body position or surroundings.The call center was unable to determine a root cause of the issue above.Although the patient has been pressing the on button when attempting to sync to the ins incorrectly, the patient did not admit to pressing the off button.The patient was advised to have the system assessed at the healthcare provider's (hcp) office using a clinician programmer (cp) so they can check for any impedance/other functional anomaly.Patient further states therapy has not controlled their target urinary frequency/urgency symptoms since implant; they get the frequent urge to "pee." the patient has tried multiple programs, but none of them have been effective.The patient met with their local rep regarding the lack of symptom control.The rep gave them program 4, but it was not effective so they changed back to program 1.The patient spoke with their managing hcp who instructed the patient their symptom control will gradually improve because they've had the target symptoms for so many years.The patient does feel stimulation in the correct area at the time of the call.As a result of what was reported, the patient was advised to review any directions given to them by their hcp and therapy expectations 50% reduction in symptoms.It was lastly reviewed to follow up with the hcp if the problem does not resolve.Additional information was received from the rep who said they received a text on (b)(6) 2018.Patient said the support line asked them to check with the hcp's office to have their device checked with a cp.The patient further said whenever they connect, they get an immediate sensation as though the internal device was turned on even though they didn't make a change.The patient said the support line thinks this is not normal and had them connect to the device a few times.After pressing sync, the same thing occurred.The patient was asked to contact their hcp so everyone could meet, but the patient's hcp hasn't responded.Nine days later, the patient called the rep because the hcp's office advised the patient to contact the rep.The rep went to the hcp's office on (b)(6) 2018 and an appointment is set up on (b)(6) 2018 at 10 am.At this time, the rep will interrogate the patient's device.The rep will ask the hcp to manage the patient and will make any changes upon hcp's request; the findings will be reported at a later time.The patient has since turned up their device from 1.1v to 1.6v.No further patient complications have been reported as a result of this 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 and it was reported that clinically the patient was doing really well and voids were down from 20 to 8 and zero voids at night.No actions had been taken and it was reported that patient still felt stimulation down their leg when they turned it on.Patient was asked if it was causing them any problems and doctor could not get the patient to express that it was a serious issue, so the doctor did not make any changes with the device.No further complications were reported.
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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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Manufacturer Narrative
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Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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 a consumer.Patient reported the same concerns as previous.Patient pt indicated they met with a manufacturer representative (rep) who communicated to patient that the device was not turning off.Patient did however continue to suspect that the machine was shutting off and it still felt that way.Patient had kept on going more and more to the restroom, and then 3 or 4 days will go by and they would press the sync and then feel some change to stim sensation and feel they had more control over their bladder.Patient also mentioned that when they stretch or go to a chiropractor it seemed like it shuts off.Patient states when they stretch at the chiro or do yoga they would feel nothing but they were thinking the machine shuts off or goes into some mode where it was not working.Patient also said when they stretch, they would go to the bathroom more often.They can also feel pain where the stimulation was supposed to be.The last time patient went to the hcp, they offered to give him a record of all the times patient was going to the bathroom, and it did reduce the symptoms by half compared to baseline, however they still were experiencing periods where they had a loss of therapy until synching with the patient programmer again.It was reviewed expectations that pressing the synch button only establishes telemetry.Patient confirmed they were only pressing the sync key, not on or off keys.It was also reviewed expectations regarding stim sensation and positional movement.Patient inquired if the ins could be defective.Recommended that patient address concerns with hcp.No further complications were reported or anticipated.
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