MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM X; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 97800 |
Device Problems
Intermittent Continuity (1121); Failure to Deliver Energy (1211); Application Program Freezes, Becomes Nonfunctional (4031)
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Patient Problem
Discomfort (2330)
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Event Date 02/17/2024 |
Event Type
malfunction
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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 were having a lot of problems because the system goes off every 30 minutes.Agent asked patient to clarify and they say that the handset does not stay connected and it turns the therapy off.When this happens the patient states they start to experience discomfort in their vaginal area.Patient states everything was fine the first 24 hours but then they started having these issues.Patient also stated they saw a system error code 0x6248552 today after they needed to continue reconnecting.Patient services assisted patient with connecting the handset and communicator to the implant.Patient service reviewed device function and recommend patient decrease the stimulation if it's causing discomfort.The troubleshooting steps that were taken on the call resolved the issue.Agent reviewed if system error code continues to contact their managing doctor to have device checked.
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Manufacturer Narrative
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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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Additional information was received from a manufacturer representative (rep).The rep reported that they have tried reaching out to the patient multiple times with no response.The account got ahold of the patient and rep will be meeting with the patient and hcp on monday (b)(6) 2024.
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Manufacturer Narrative
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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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