Model Number 37612 |
Device Problems
Improper or Incorrect Procedure or Method (2017); Battery Problem (2885)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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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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Patient rep was wanting information on how to use the recharger.The rep stated that the previous healthcare worker stopped using the recharger because " it wasn't working".Rep stated that they are unsure if the implantable neurostimulator (ins) has been charged in the last 30 days or if the ins is still turned on.Patient services (pss) explained to the rep what the overdischarged state of the ins means.Rep said they were not with the equipment or the patient to further troubleshoot.Pss sent an email to the rep with the recharger user manual and redirected the caller to their provider to further assist.No symptoms were reported.
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Event Description
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Caller reported patient (pt) has not charged implantable neurostimulator (ins) in about 2 years.Technical services (ts) provided instructions for doing passive mode recharge.No symptoms reported.Reviewed steps and sent document related to physician recharge mode.Caller inquired about a quick guide for recharger but tech services (tss) reviewed we no longer have one.Caller stated they saw power on reset message and ins is charging normally with the first quartile showing solid.Tss reviewed next steps to complete bringing ins out of overdischarge.No symptoms reported.
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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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Additional information was received stating that the cause of the overdischarge was that the patient has healthcare aides 24/7.With a change in staff a few months ago, they did not know how to recharge the patients implantable neurostimulator (ins).It was overdischarged for about 7-8 months.The patient was taken out of overdischarge on (b)(6) 2024 and the ins was recharged to 100% after the por was completed.However, on the morning of (b)(6) 2024 the ins was again depleted and was off.The ins was recharged to 25% and turned back on by the healthcare aide, and then charging was continued to 100%.
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Search Alerts/Recalls
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