MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM X; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 97800 |
Device Problems
Labelling, Instructions for Use or Training Problem (1318); Migration or Expulsion of Device (1395); Insufficient Information (3190)
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Patient Problems
Incontinence (1928); Pain (1994); Urinary Frequency (2275)
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Event Date 11/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id: 978b128, lot# va2n3f3, product type: lead.Other relevant device(s) are: product id: 978b128, serial/lot #: (b)(4), ubd: 03-mar-2024, udi#: (b)(4).Date of event: date is estimated; month and year are valid.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.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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Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary/bowel dysfunction and urge incontinence.It was reported that two months ago noticed return of symptoms, going to the bathroom too much.Patient said that did have a fall in october and did have x-rays performed and said that everything seems fine.Patient then said that in december has noticed having more leakage, however commented that was drinking more water than usual.Patient also mentioned that last week the wiring seems more thicker in the skin than it was before and last night patient's husband said that the wire moves around.Patient also mentioned that when sits down, hurts right where the wire is at.Reviewed therapy information and general programming guidance.Patient said that was at 5.2.However, when checked today, the setting was at 2 and they increased to 4.2.Patient didn't make any additional adjustments during the call.Confirmed stimulation in bicycle seat area and comfortable.Patient will maintain stimulation level and will continue to track symptoms.Patient was redirected to schedule appointment with doctor if issue to address concerns about wire and schedule device check to address concerns about settings changing. patient also said that when placed into mri mode that their last name was missing a letter at the end.Redirected patient to schedule device check with the person that performs the programming and they will be to edit the name.
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Search Alerts/Recalls
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