Model Number 37612 |
Device Problem
Failure to Deliver Energy (1211)
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Patient Problems
Pain (1994); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)
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Event Date 04/24/2020 |
Event Type
malfunction
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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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It was reported late last week, they noticed a lot of movement going on and it reminded them of pre-surgery time.It was getting bad, painful, and worse.On sunday, they noticed their implant was off on the patient programmer (pp) screen.They are not sure how the implant was turned off.They asked if the ins turns itself off when the ins is low and how do they find out when the ins was off and for how long.Patient services reviewed ins functionality and recommended keeping the ins charged up.They were able to turn the ins on and will never let the ins get low again.They stated the rechargeable is new for them because they had the non-rechargeable before and they are learning.It was recommended for the patient to consult with their healthcare provider (hcp) office regarding checking the ins for recharging and ins turning off.
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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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Search Alerts/Recalls
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