Model Number 37612 |
Device Problem
Delayed Charge Time (2586)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/01/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The event date is an estimated date.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported it takes longer to charge, about 1.5-2 hours to full when starting at 75%.Previously, they would charge every three days for 45 minutes.The patient's amplitude used to be at 5.1 ma but it has been at 5.8 ma since march.They believe this issue started around march time frame when the patient had the appointment.Troubleshooting included reviewing that with 75% quartile, the ins charge can be anywhere from 50-75% so the patient may be starting to charge at a different level than before or their coupling may have changed.It was suggested to have the patient continue to charge normally and review 8840 and implantable neurostimulator recharger (insr) stats at next appointment for further troubleshooting.No patient symptoms were reported.
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Manufacturer Narrative
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Product id: 37651, serial# (b)(4), product type: recharger.If information is provided in the future, a supplemental report will be issued.
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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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Additional information was received from a consumer reporting that it took 2 hours to charge the implant to full from 75% the last two times they charged their implant.They spoke with a manufacturer representative (rep) today and met with their doctor's office who told them to call and get a new insr as everything looked okay on their end.The patient is getting full coupling boxes when charging.It was explained that if they are still having the same problems with the new insr, they will need to follow up with their hcp.A replacement insr was sent.
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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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Search Alerts/Recalls
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