MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 3058 |
Device Problems
Display or Visual Feedback Problem (1184); Communication or Transmission Problem (2896); Insufficient Information (3190)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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Information was received from a healthcare provider regarding a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor.It was reported that patient was having difficulty trying to connect to ins to turn off/put in mri mode.Tss walked caller through process and caller was getting 'different device detected' when trying to using mytherapy app.The caller eventually said this is not the patient's handset but the facility's handset.Tss had caller try to 'manage devices' but the caller states there was no gear/menu option.Tss had caller select (b)(4) and it said 'different device detected' in the clinician app.Tss had caller try the correct sn (b)(4) and a message came up 'programming data of existing device will be deleted'--the caller had no other options.The caller selected 'continue' on the correct sn (b)(4) and the caller then exited the app and went to mytherapy app at this time, the caller was able to access the ins but it appears there all the data was wiped and there is no programming, however, the caller was able to confirm that the ins was off for head mri.Caller states patient heard that programming may be wiped and the patient said 'they don't care' because they were unsure if it (system) was working.
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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.
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