MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
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Model Number 37612 |
Device Problems
Failure to Interrogate (1332); Improper or Incorrect Procedure or Method (2017); Battery Problem (2885); Communication or Transmission Problem (2896)
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Patient Problems
Muscular Rigidity (1968); Ambulation Difficulties (2544)
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Event Type
malfunction
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Event Description
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Information was received from a manufacturer's representative (rep) regarding an implantable neurostimulator (ins).The reason for call was rep said healthcare provider (hcp) called because patient is at the end stage of his life and hcp wanted to make patient as comfortable as possible.Hcp reported patient symptom of rigidity and bradykinesia has been worse.Rep was contacted yesterday and the patient programmer and recharger won't connect to the neurostimulator, thus rep thinks the implant might be in overdischarge, but she didn't know how long it might have been overdischarge.Rep to see patient and do physician recharger mode (prm).Technical services (ts) reviewed how to start prm with recharger (insr) and wireless recharger.The caller was not with the patient.Reviewed what the recharger should look like when it's doing the physician recharge mode(prm).Reviewed what it should look like when patient is recharging.Reminded rep that she needs to clear por once implant is charging.
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Manufacturer Narrative
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B3: event date is not known.Please see b5 for approximate date range, if applicable.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 received from the manufacturer¿s representative (rep), which was confirmed with the healthcare provider (hcp), reported the cause of the overdischarge was due to the patient not charging it as they lived in a nursing home and didn¿t have assistance charging it.A jumpstart was performed which took 1.5 hours and the device was charged to 25%.The next day it took 5 hours to charge to 75%, and in two days it went back down to 25%.
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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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