MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM X; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 97800 |
Device Problems
Electromagnetic Interference (1194); Failure to Deliver Energy (1211); High impedance (1291); Application Program Problem (2880)
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Patient Problems
Micturition Urgency (1871); Incontinence (1928); Urinary Frequency (2275); Ambulation Difficulties (2544); Cognitive Changes (2551); Urinary Incontinence (4572); Insufficient Information (4580)
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Event Type
malfunction
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.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 and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee 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 regulatory reporting.Medtronic objects to the use of these words and others like them 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.
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Event Description
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Information was received from a patient via a manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction (incontinence, urgency, and/or frequency).It was reported that the rep spent over 45 minutes with patient at a device follow-up appointment.Patient stated an mri was ordered in aug 2022.Patient stated x-ray tech put device in mri safe mode or turned device off before mri at (b)(4) fl.Patient returned to (b)(4) fl for a second mri in sept.2022.Patient was told by radiology administration that they could not have the mri done and should not have had one done in aug.At their facility.Patient was seen at normal interstim clinic on 9/28 and reported falls and clinic ordered x-rays.At this time patient did not mention any mri information.X-rays were normal.Patient was then seen on 12/7 at interstim clinic stating that device is not working; urinary urgency, urinary frequency, and urinary incontinence symptoms have returned but not daily.The patient has also experienced a worsening of their baseline symptoms of urge incontinence and urgency frequency and walking difficulty/immobility/loss of balance/unable to get out of bed.We attempted to make a program change, but then samsung controller displayed error message "maximum settings - the system is operating at the maximum setting.Therapy cannot be increased." received this message on programs 1-4 at 0.3 amps.Impedance check was performed and results were 4000 on all 4 electrodes and within all 4 electrodes as well.Patient experienced a loss of stimulation or no stimulation.Patient's device is now off.Second set of x-rays will be ordered and patient is scheduled to return 12/14 to interstim clinic.Rep stated they didn't think the mri in aug did anything since patient symptom was good on sept 28th hcp visit.Rep believed something happened between sept 28 and yesterday that caused system issue.Rep said patient mentioned good days and bad days.Rep said patient might have cognitive deficiency thus reports from patient wasn't reliable.
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