MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 3058 |
Device Problems
High impedance (1291); Migration or Expulsion of Device (1395)
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Patient Problems
Diarrhea (1811); Micturition Urgency (1871); Pain (1994); Urinary Frequency (2275); Fecal Incontinence (4571); Insufficient Information (4580)
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Event Date 06/01/2023 |
Event Type
Injury
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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.It was reported that patient came in on (b)(6) 2023 to have their lead and battery replaced.They stated on or around (b)(6) 2023, they began having loose stools and fecal incontinence along with an increase in urgency and frequency.They stated they did not have that problem prior to (b)(6) june.They went to a gastroenterologist for a consultation of their gastrointestinal status.The gastroenterologist told them that everything looked fine from a bowel standpoint.Then they made an appointment and saw their urologist, who placed the device, in august of 2023.Their staff switched their program and interrogated the device.They did an impedance check which revealed high, out of range impedances on electrodes 0, 1, and 2.This was in august 2023.In august 2023, an x-ray of the sacrum was ordered which revealed that the lead had migrated.The patient also began to have rectal pain after they were seen in their dr's office in august 2023.At that point they turned the device off.They were on program 5 at 5.0.The patient denied any falls or accidents leading up to the change in therapy, which was an increase in urinary urgency and frequency along with loose stool and fecal incontinence starting around june 1, 2023.On october 18, 2023, the patient had a full replacement of both lead and battery.Postop the patient felt the stimulation comfortably in the vaginal area at 1.1 a.The issue was resolved.
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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: va2hvla); product type: 0200-lead.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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