MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
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Model Number 3058 |
Device Problems
Display or Visual Feedback Problem (1184); Malposition of Device (2616)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
Injury
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Manufacturer Narrative
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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 and gastrointestinal/ pelvic floor.It was reported that they need to have implant moved deeper as patient has lost a lot of weight.Patient said started losing weight in august 2021 and sometime later in 2021 is when noticed changes to ins site.Patient said is scheduled for revision on (b)(6) 2022.The patient was redirected to their healthcare provider (hcp) to further address the issue.Furthermore, patient said they placed into mri mode at mri appointment the day prior to the report and it didn't say full body however patient doesn't remember what the screen said.Reviewed information.Patient said that they called and spoke with medtronic representative about this and was told that based on device information patient can have mri.Unable to perform troubleshooting as patient did not have product.Patient to call back when has product to review screens or call medtronic representative and schedule an appointment to check screen and programming.
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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 and gastrointestinal/ pelvic floor.The caller indicated that they had the patient activate mri mode and the remote showed head only eligible.The caller indicated that when mri mode was activated, the device information showed that the implanted lead was model 3889.On 3 jun 2022 an mdt rep called the mri facility and told them that the patient was eligible for the knee scan.Troubleshooting was not required.The issue was not resolved through troubleshooting.Tss reviewed mri information.The caller will direct the patient to follow-up with the managing urologist.
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Search Alerts/Recalls
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