Model Number 37612 |
Device Problems
Improper or Incorrect Procedure or Method (2017); Battery Problem (2885); Charging Problem (2892)
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Patient Problems
Unspecified Nervous System Problem (4426); Cramp(s) /Muscle Spasm(s) (4521); Insufficient Information (4580)
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Event Date 10/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The event date is an estimated date.Please note that this device was used in an off-label manner as it was implanted for dystonia.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 that the patient's implantable neurostimulator (ins) has been off since 2019.The patient's dystonia is getting worse now and they wanted to turn the ins back on.The patient attempted to charge and they indicated that the recharger recognized the implant but the ins would not charge.The patient did not have the recharger available at the time of the call therefore, troubleshooting was unable to be performed.The programming manual with information about conducting a physician recharge mode (prm) 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.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 healthcare provider (hcp) reporting that the patient had the deep brain stimulation (dbs) in 2008 and it took months of adjusting before he got a good response.The patient responded well from 2008 to 2017.The patient had the rechargeable ins implanted in 2018 and the physician did not see the patient again until march 2019.In 2017, the patient's symptoms in the legs and hands started to get worse.The patient felt like stimulation wasn't helping him, so in 2019, the patient elected to not use the stimulator.The patient was not able to charge their ins before the ins was in overdischarge sometime last week.The physician recently brought the ins out of overdischarge on 2021-(b)(6) via two prm sessions.They adjusted voltage to one group and the patient stated he wanted to wait to turn stimulation on de to spasms post-adjustment.The patient indicated that since coming out of overdischarge, the "battery will not hold a charge" and finds the ins is discharging rapidly.The patient had charged up friday night and saturday morning, the ins was down to 0%.
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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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