Model Number 37712 |
Device Problems
Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885); Charging Problem (2892); Insufficient Information (3190)
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Patient Problems
Ambulation Difficulties (2544); Electric Shock (2554); Insufficient Information (4580)
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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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Information was received from a patient (pt) regarding an implantable neurostimulator (ins).The reason for call was starting a couple years ago the pt would not turn their stimulation on when they are laying down for it "barbeques" them; pt stated that their implant zaps them.Pt stated that they're fine when walking around while the stimulation is turned on.Pt thinks that their implant battery needs to be replaced and about a year and a half ago the pt tried to get referrals from their hcp about their implant.The patient was redirected to their healthcare provider to further address the issue.The patient further reported that it takes them 5 hours to charge their implant and they have to charge their implant every 2 or 4 days for their implant depletes a lot quicker now (pt stated that they only had to recharge their implant every 10 days when they first were implanted).Caller was redirected to the healthcare provider (hcp).
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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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Event Description
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Additional information was received.It was reported their device no longer held a charge.The battery was not working and the patient could barely walk.
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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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Event Description
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Additional information was received from a consumer, the caller said it still was not working and realized the recharger antenna cord was loose which could be why the implant was not getting a good charge.They were not getting a stable connection when charging.They mentioned the screw was loose and "they don't trust it".A replacement recharger (insr) antenna was sent out.
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Search Alerts/Recalls
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