MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 3058 |
Device Problems
Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cognitive Changes (2551); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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Information was received from a healthcare professional (hcp) regarding a patient with an implanted neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor therapy.It was reported that the patient had an image obtained 3 days ago in which the notes read that the "lead appears clearly disconnected from the ins".Troubleshooting asked if patient had mentioned anything the device or therapy not working or any system history and caller stated no, they were just learning about this from the imaging and that patient "wasn't themselves" when they came to the facility.The caller was not with the patient.Troubleshooting reviewed that if there is concern the lead is disconnected, our guidelines don't speak to this configuration since the system isn't complete and we wouldn't recommend scanning the patient.Troubleshooting suggested contacting the managing hcp to see if they had any more information about the history of patient's system but, ultimately if the system needed to be revised, replaced or explanted, this would be a surgical procedure.
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Manufacturer Narrative
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Concomitant medical products: product id 3889-28, lot# va0nc5w, implanted: (b)(6) 2015.Other relevant device(s) are: product id: 3889-28, serial/lot #: (b)(4) ubd: 05-sep-2018, 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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