MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM X; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 97800 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problems
Incontinence (1928); Discomfort (2330)
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Event Date 04/12/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Section d references the main component of the system.Other medical products in use during the event include: brand name surescan; product id 978b128 (lot: va2v67p); product type: 0200-lead.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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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 dysfunction/sacral nerve stim.It was reported that the patient had discomfort/soreness/pinching/ache/pressure, return of baseline symptoms urinary incontinence.Patient seen in office complaining of no symptom relief and pain with stimulation.Mapping was performed in the office a nd impedance.Impedance was normal but electrodes 3 and 2 caused tailbone sensation.Hcp was made aware and an x-ray was performed which showed lead movement up into the foramen.Rep was able to obtain vaginal sensation by isolating the number 1 electrode.Patient to follow up with hcp and field contact in 6 weeks for reevaluation.
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Manufacturer Narrative
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A4: patient weight added.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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