MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM X; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 97800 |
Device Problems
Failure to Deliver Energy (1211); Electromagnetic Compatibility Problem (2927)
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Patient Problems
Incontinence (1928); Nausea (1970); Dizziness (2194); Insufficient Information (4580)
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Event Date 08/09/2023 |
Event Type
malfunction
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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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Information was received from a patient regarding an implantable neurostimulator.It was reported that patient said they had a kidney stone(unrelated) removed on the 9th.Patient said there were complications and they couldn't remove the stone the first time so they had to go in twice.The patient is still hospitalized due to that (unrelated).Patient tried to turn therapy back on after the procedure, but it won't stay on.Patient is back to wetting their pants.Patient also said they are nauseous and dizzy.The patient was difficult to understand and was medicated at the time of the call and reported being on oxycodone.Attempted to help patient with external devices and the patient was not feeling well.Patient will rest and call back later.
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Event Description
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Additional information was received from the patient (pt).Patient called back and repeated information regarding kidney stones.Patient stated since then their symptoms had returned and were worse.They couldn't control anything and it "gushes".Patient stated they have tried making adjustments before.Patient services had patient connect to ins and increase stimulation to a comfortable level.Patient will maintain stimulation and monitor symptoms.Again reviewed external devices being off versus ins being off.
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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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