MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 3058 |
Device Problems
Unintended Collision (1429); Insufficient Information (3190)
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Patient Problems
Twitching (2172); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/11/2024 |
Event Type
Injury
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Manufacturer Narrative
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B3: date is approximate.Month and year are confirmed valid.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: va2cn7f); 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 stimulation and gastrointestinal/pelvic floor.It was reported that the patient fell on the stairs and the healthcare provider (hcp) told them they jolted a couple of the wires in their back.The caller confirms they saw the ins doctor on monday (b)(6) 2024 and they cannot revise the ins until after the fracture in the ankle heals.The caller also reports that every once in a while they feel a twitching down by their tailbone.The patient was redirected to their healthcare provider to further address the issue.
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Manufacturer Narrative
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Concomitant medical products: product id: (b)(4), lot#: (b)(4), product type: 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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Additional information was received, from the patient.It was reported, that they clarified, the statement.Jolted a couple of wires and reported, that the wires came out.The cause of the jolt was determined, to be due to the patient fall.The patient will be having surgery to fix the issue.Date of surgery unknown.Patient made an appointment with their healthcare provider for (b)(6) 2024.
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Manufacturer Narrative
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Continuation of d10: product id 978b128.Lot# va2cn7f, product type 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 an unknown source regarding a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim, incontinence, urgency, and/or frequency.It was reported that there was an high impedance issue.The impedance values were 3-0 (1.2), 2-3,1-3,0-3.There were no other stimulation issues reported.No troubleshooting was performed and the cause was unknown.The last time they met with the manufacturing representative they had custom programs added due to the impedances.The patient was supposed to try 2 of the custom programs, however only tried 1.The impedances were retested and still there, so custom program b was added.The patient had forgotten their remote.The issue was ongoing.
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