Model Number 37800 |
Device Problems
Disconnection (1171); Insufficient Information (3190)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/12/2021 |
Event Type
Injury
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Manufacturer Narrative
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Date is approximate with year validity.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 gastrointestinal/ pelvic floor.It was reported by the patient that they noticed about 2 months ago, they started suffering, having a really hard time, and that today, the patient feels they have an emergency with their enterra device.The patient stated that their implanting doctor no longer worked with enterra and that their new doctor told them yesterday that the lead was disconnected, they used their equipment and found no power to one of the leads.The patient reported that the doctor wanted to take the enterra out and do gastric bypass (not alleged to be related to the device/therapy,) but the patient wanted their system checked and adjusted.The patient said they have called other doctors but the other doctors were not taking new patients.The patient was redirected to their healthcare provider to further address the issue and patient services reached out to the field to help the patient locate a doctor.The name of a doctor to contact was provided to the patient.Patient services did call the patient back to advise them if they were having a medical emergency that they should seek medical intervention if they chose.
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Event Description
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Additional information was received from the patient.They reported that there was some sort of malfunction/lead failure, which was confirmed by the doctor on (b)(6) 2021.The cause was not identified, the patient noted no change in adl's or strenuous activities.They underwent replacement surgery on (b)(6) 2021,which resolved the issues.They noted the lead failure caused a disruption in treatment, relapse in symptoms and they were out of work for almost a month.They noted it was evaluated for malfunction/defect and frequency testing showed no connectivity of the lead.
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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.
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Search Alerts/Recalls
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