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
Flatus (1865); Unspecified Infection (1930); Pain (1994); Urinary Retention (2119); Insufficient Information (4580)
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Event Type
Injury
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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 who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim.The reason for call was patient said they are not too happy about the way it is working.Patient said they have an appointment tomorrow at 11: 45 at the hcp's office.Pt said they saw the technician a couple of weeks ago and they think they got a call saying there was a change to their appointment tomorrow, the hcp won't be there they are not sure who the appointment will be with.Patient asked if a manufacturer representative could be present at their appointment tomorrow.Reviewed the role of the representative and offered to send an email to the field to see if a representative could get in touch with the patient.The patient was redirected to their healthcare provider to further address the issue.Patient said their stimulator helped to a degree but it hurts, they feel like they might have an infection in the testicle and it has been a while.Redirected to their doctor for medical symptoms.
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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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Additional information was received from the patient.Pt described symptoms and requested a rep appointment, stating they had met with the medtronic rep, who made an adjustment but still has symptom issues.Pt said they have not used the equipment on their own.Another email will be sent to the field to try and have a rep get in touch with the patient and re-direct the patient to their doctor's office to arrange for a rep appointment as well.Pt said since the implant, they still have bladder and bowel issues: when they urinate, they are full of gas and feel like they want to move their bowels; they are still getting up 4-5 times and have to run to the bathroom; and sometimes they have to use the urine bottle while dripping.Pt believes their bladder is never empty.
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Search Alerts/Recalls
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