MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM X; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 97800 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Diarrhea (1811); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Urinary Retention (2119); Burning Sensation (2146); Discomfort (2330); Cramp(s) /Muscle Spasm(s) (4521)
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Event Date 03/06/2024 |
Event Type
Injury
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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 since last night has experienced a lot of bladder spasms and keeps on getting the urge to void however nothing comes out.Patient also said that lately when goes to the bathroom has experienced loose stool, like diarrhea.Patient said that when they wipe, they are raw, bleeding and burning.When asked, patient said hasn't had any changes to any of the medications.Patient called managing physician's office and was told to contact manufacturer for programming assistance.Patient asked for direction on how to make an adjustment.Reviewed therapy information and general programming guidance.With instruction patient connected to implant and adjusted setting however said stimulation was uncomfortable so decided to switch programs.Patient will maintain stimulation level and will continue to track symptoms.The patient mentioned related medical history.This included that patient said that they were told by pcp that they have an active bladder told to avoid certain types of food and patient also mentioned that prior to implant found out that they has a damaged bladder nerve.Patient was redirected to follow up with managing healthcare provider for further questions about therapy and to report changes to bowel symptoms.Patient said is scheduled to see their pcp about bowel symptoms later this afternoon.
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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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