MEDTRONIC MED REL MEDTRONIC PUERTO RICO INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 3058 |
Device Problems
Disconnection (1171); Inappropriate/Inadequate Shock/Stimulation (1574); Insufficient Information (3190)
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Patient Problems
Electric Shock (2554); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
Injury
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Manufacturer Narrative
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B3: event date is not known.Please see b5 for approximate date range, if applicable.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 the treatment of bladder issues.It was reported that their bladder stimulator had been broken for about 5 years and needed to be explanted.Patient stated it was malfunctioning and something disconnected in there and it didn't work anymore.Patient stated they don't know any further details or when this occurred.Patient states since then they had no use for the programmer so they no longer have it, but now they want to do an mri of the breast.Agent reviewed mri info and recommended the patient follow up with the doctor.Agent provided doctor's name on file to contact.The patient was redirected to their healthcare provider to further address the issue.
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Event Description
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Additional information was received from the patient.The patient stated the stimulator was placed many times.The first time their body pushed it out, the second time it only worked for about a year, and that's been about 15years ago.The cause of the device not working was not determined.Patient stated it seemed to be malfunctioning and started shocking them, then it stopped all together.Patient will be having device removed (b)(6) 2024.Issue has not yet resolved.
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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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