MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 3058 |
Device Problems
No Device Output (1435); Battery Problem (2885); Electromagnetic Compatibility Problem (2927)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/14/2023 |
Event Type
malfunction
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Event Description
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Information was received from a patient (pt) with an implanted neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor therapy.It was reported that they had a hysterectomy on tuesday, they had trouble but were able to turn stim off but after the surgery they could not turn it back on they got a picture of a doctor.Asked pt to synch with their ins during the call and pt said they see a por message.Reviewed por information and redirected to their doctor.Pt said they no longer see that doctor and their new doctor did not know about interstim.Offered and sent physician listings.Redirected to their healthcare provider to further address the issue.Additional information was received from the patient.An outbound call was made to the patient due to phone issues and patient repeated por message.Agent reviewed meaning of por.When asked, patient said last week on tuesday had hysterectomy and said did turn off the stimulation beforehand.Patient called listings however said the earliest they can be seen is in january.As requested, checked listings again and reviewed information.Provided nas phone number in case current hcp office might consider inviting the medtronic rep to check device status.
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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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