MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM X; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 97800 |
Device Problems
Energy Output Problem (1431); Application Program Problem (2880); Insufficient Information (3190)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/05/2023 |
Event Type
Injury
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Manufacturer Narrative
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Continuation of d10: product id 3889-28 lot# va1zc63.Implanted: (b)(6) 2019.Product type lead section d information references the main component of the system.Other relevant device(s) are: product id: 3889-28, serial/lot #: (b)(6), ubd: 10-apr-2023, udi#: (b)(4).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 they had their new implanted device placed on thursday and the healthcare provider set the stimulation at "0.7 instead of 7".Patient said they tried to increase the stimulation and saw a message that said they were at their maximum setting.Patient service specialist walked patient through changing programs.Patient was able to increase stimulation on the current program to a comfortable level.Patient was redirected to hcp regarding message.Additional information was received from the patient.It was reported that the cause of the maximum settings reached message when trying to increase stimulation was unknown.Additional information was received from the patient.They reported that the cause of trying to increase the stimulation but seeing a maximum setting message was bad wires.Additional information was received from a healthcare professional (hcp).When asked to clarify ¿bad wires¿ the hcp reported they were unsure of bad wires.The patient had ins battery implanted on (b)(6) 2023.The rep was notified to adjust the setting.Additional information was received from a manufacturer representative (rep).The rep reported that the patient did not get a new lead.There is a planned revision for (b)(6) 2024.Rep does not recall any specifics regarding the bad wires.
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Event Description
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Additional information was received from a manufacturer representative (rep).The rep reported that the cause of the max settings and bad wires was unknown.This was resolved by changing the lead out on (b)(6) 2024.
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Manufacturer Narrative
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Continuation of d10: product id 3889-28, lot# va1zc63, implanted: (b)(6) 2019, explanted: (b)(6) 2024, product type 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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