MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
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Model Number 3058 |
Device Problems
Unintended Collision (1429); Energy Output Problem (1431); Battery Problem (2885); Insufficient Information (3190)
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Patient Problems
Diarrhea (1811); Hemorrhage/Bleeding (1888); Incontinence (1928); Inflammation (1932); Pain (1994); Urinary Frequency (2275); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 07/31/2023 |
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 gastrointestinal/pelvic floor therapy and fecal incontinence.It was reported that a couple of weeks ago they fell and blacked out.Pt stated now they're pretty much incontinent and are having serious issues with their bowels.Patient said they are not sure if the device is working.Patient stated they are unable to make any adjustments because they cannot get the two units to work.Patient was able to connect to implanted neurostimulators but saw internal device has lost all data contact your clinician.The issue was not resolved through troubleshooting.The patient was redirected to their healthcare provider to further address the issue.
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Manufacturer Narrative
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Date is estimated; year is valid.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 healthcare professional (hcp).The hcp responded to a fax by attaching the patient's office visit notes.Within the notes, it was determined that the patient was seen on (b)(6) 2023 with a recent history of increased frequency and lower left quadrant abdominal pain.The patient presented to discuss a recent fall while having some dehydration issues on their backside and worsening fi symptoms.It was noted that the patient was positive for blood in their stool, had diarrhea and rectal pain.Incontinence and hemorrhoids were noted as well as perianal irritation.It was reported that the interstim unit was interrogated by the clinician programmer to check impedance levels, battery life and program settings.Interrogation revealed a non-functioning unit, likely the product of the injury in which the patient fell on their backside.
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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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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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Event Description
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Additional information was received from the patient.They reported that they think when they fell it destroyed the device so they put another one in.
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Search Alerts/Recalls
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